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Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

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ClinicalTrials.gov Identifier: NCT00121641
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : May 11, 2011
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Saxagliptin
Drug: Placebo matching Saxagliptin
Drug: Metformin
Drug: Placebo matching Metformin
Enrollment 1035
Recruitment Details  
Pre-assignment Details 1035 subjects were enrolled; 422 entered the 2-week dietary/exercise placebo lead-in. 21 did not enter double-blind treatment period (19 discontinued, 2 randomized but did not receive study drug). 68 with screening hemoglobin A1c (A1C) >10.0% and ≤12.0% entered directly in the open-label cohort; 66 received at least 1 dose of saxagliptin 10mg.
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]); Metformin 500-2000 mg (as needed for rescue). Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Period Title: 24-week Short-term Treatment Period
Started 102 106 98 95 66
Completed 73 68 69 55 25
Not Completed 29 38 29 40 41
Reason Not Completed
Lack of Efficacy             15             21             14             25             30
Subject Withdrew Consent             9             11             5             10             3
Adverse Event             3             3             4             0             2
Lost to Follow-up             0             2             3             4             4
Poor / Non-compliance             0             0             3             1             1
Subject No Longer Meets Study Criteria             1             1             0             0             1
Other Reason             1             0             0             0             0
Period Title: 48-month Short Term + Long Term Period
Started 102 106 98 95 66
Completed 23 24 28 24 8
Not Completed 79 82 70 71 58
Reason Not Completed
Lack of Efficacy             26             27             21             26             25
Subject Withdrew Consent             25             28             17             24             10
Adverse Event             9             10             10             5             5
Lost to Follow-up             9             7             12             11             12
Poor / Non-compliance             4             1             4             2             2
Subject No Longer Meets Study Criteria             1             3             2             1             2
Pregnancy             0             1             0             1             0
Administrative Reason by Sponsor             0             2             1             0             1
Death             0             0             0             1             0
Missing             0             0             1             0             0
Other Reason             5             3             2             0             1
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo Total
Hide Arm/Group Description Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) Total of all reporting groups
Overall Number of Baseline Participants 102 106 98 95 401
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 106 participants 98 participants 95 participants 401 participants
53.27  (10.06) 53.91  (11.57) 52.73  (11.27) 53.91  (12.32) 53.46  (11.29)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 102 participants 106 participants 98 participants 95 participants 401 participants
<65 years 91 86 84 77 338
>= 65 years 11 20 14 18 63
>=75 years 2 1 1 2 6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 106 participants 98 participants 95 participants 401 participants
Female
44
  43.1%
52
  49.1%
53
  54.1%
48
  50.5%
197
  49.1%
Male
58
  56.9%
54
  50.9%
45
  45.9%
47
  49.5%
204
  50.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 102 participants 106 participants 98 participants 95 participants 401 participants
White 89 93 80 79 341
Black/African American 5 5 6 6 22
Asian 5 4 6 3 18
Other 3 4 6 7 20
Not Reported 0 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Partcipants
 Number Analyzed 102 participants 106 participants 98 participants 95 participants 401 participants
Hispanic / Latino 16 14 14 15 59
Not Hispanic / Latino 45 49 42 38 174
Not Reported 41 43 42 42 168
Age Categorization, Female Only  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 102 participants 106 participants 98 participants 95 participants 401 participants
=< 50 years 17 24 22 19 82
> 50 years 27 28 31 29 115
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 102 participants 106 participants 98 participants 95 participants 401 participants
92.10  (18.39) 91.09  (18.53) 89.30  (17.67) 86.56  (16.90) 89.84  (17.96)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 102 participants 106 participants 98 participants 95 participants 401 participants
31.90  (4.82) 32.30  (4.53) 31.71  (4.71) 30.93  (4.26) 31.73  (4.60)
Body Mass Index Categorization  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 102 participants 106 participants 98 participants 95 participants 401 participants
< 30 36 40 35 42 153
>= 30 66 66 63 53 248
1.Primary Outcome
Title Hemoglobin A1c (A1C) Changes From Baseline at Week 24
Hide Description To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with both a baseline and post-baseline value (up to Week 24).
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: Percentage of glycosylated hemoglobins
Baseline Mean 7.91  (0.09) 7.98  (0.11) 7.85  (0.09) 7.88  (0.10)
Adjusted Mean Change from Baseline -0.43  (0.10) -0.46  (0.10) -0.54  (0.10) 0.19  (0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin 2.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-0.90 to -0.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments ANCOVA model:post - pre = pre treatment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Saxagliptin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-0.93 to -0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.14
Estimation Comments ANCOVA model:post - pre = pre treatment
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Saxagliptin 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-1.02 to -0.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.15
Estimation Comments ANCOVA model:post - pre = pre treatment
2.Primary Outcome
Title A1C Changes From Baseline at Week 24 - Open Label Cohort
Hide Description To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open-label participants with both a baseline and a post-baseline (up to Week 24)
Arm/Group Title Open Label Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 64
Mean (Standard Error)
Unit of Measure: Percentage of glycosylated hemoglobins
Baseline Mean 10.70  (0.10)
Mean Change from Baseline -1.87  (0.18)
3.Secondary Outcome
Title Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 101 105 97 92
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline 177.72  (4.12) 171.31  (4.09) 176.51  (4.43) 171.85  (4.80)
Adjusted Change from Baseline -14.53  (3.82) -8.67  (3.74) -16.75  (3.89) 6.06  (4.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin 2.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.60
Confidence Interval (2-Sided) 95%
-31.47 to -9.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.53
Estimation Comments ANCOVA model:post - pre = pre treatment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Saxagliptin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0074
Comments Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.73
Confidence Interval (2-Sided) 95%
-25.50 to -3.97
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.48
Estimation Comments ANCOVA model:post - pre = pre treatment
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Saxagliptin 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.81
Confidence Interval (2-Sided) 95%
-33.79 to -11.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.58
Estimation Comments ANCOVA model:post - pre = pre treatment
4.Secondary Outcome
Title Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Participants with measurement at time point, Last Observation Carried Forward (LOCF)
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 100 103 95 92
Measure Type: Number
Unit of Measure: percentage of participants
35.0 37.9 41.1 23.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin 2.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1141
Comments Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method Fisher Exact
Comments The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 11.1
Confidence Interval (2-Sided) 95%
-3.1 to 24.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Saxagliptin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0443
Comments Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method Fisher Exact
Comments The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 14.0
Confidence Interval (2-Sided) 95%
-0.1 to 27.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Saxagliptin 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method Fisher Exact
Comments The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 17.1
Confidence Interval (2-Sided) 95%
2.8 to 31.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with measure at given time points, Last Observation Carried Forward (LOCF).
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 74 79 73 66
Mean (Standard Error)
Unit of Measure: mg*min/dL
Baseline 45030  (1368.1) 45691  (1209.8) 44614  (1394.0) 46030  (1397.8)
Adjusted Change from Baseline -6868  (1167.7) -6896  (1130.2) -8084  (1176.2) -646.6  (1236.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saxagliptin 2.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6221
Confidence Interval (2-Sided) 95%
-9570 to -2872
Parameter Dispersion
Type: Standard Error of the mean
Value: 1701.3
Estimation Comments ANCOVA model:post - pre = pre treatment
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Saxagliptin 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6249
Confidence Interval (2-Sided) 95%
-9546 to -2952
Parameter Dispersion
Type: Standard Error of the mean
Value: 1675.1
Estimation Comments ANCOVA model:post - pre = pre treatment
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Saxagliptin 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7437
Confidence Interval (2-Sided) 95%
-10798 to -4076
Parameter Dispersion
Type: Standard Error of the mean
Value: 1707.6
Estimation Comments ANCOVA model:post - pre = pre treatment
6.Secondary Outcome
Title Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open Label Subjects with Measurement at Timepoint; Last Observation Carried Forward (LOCF)
Arm/Group Title Open-Label Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 64
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline 241.08  (6.19)
Change from Baseline -33.42  (5.37)
7.Secondary Outcome
Title Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open Label Participants with measurement at time point, Last Observation Carried Forward (LOCF)
Arm/Group Title Open Label Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: percentage of participants
14.1
8.Secondary Outcome
Title Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Open Label participants with measure at given time points, Last Observation Carried Forward (LOCF).
Arm/Group Title Open Label Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 64
Mean (Standard Error)
Unit of Measure: mg*min/dL
Baseline 60687  (2312.4)
Change from Baseline -11078  (2132.8)
9.Other Pre-specified Outcome
Title Baseline Demographic Characteristic (Age, Continuous) - Summary for ST + LT Treatment Period - Open-Label Cohort
Hide Description This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Mean (Standard Deviation)
Unit of Measure: years
49.09  (8.63)
10.Other Pre-specified Outcome
Title Baseline Demographic Characteristics - Summary for ST + LT Treatment Period - Open-Label Cohort
Hide Description This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: participants
Age <65 years 64
Age >=65 years 2
Age >=75 years 0
Gender, Male 32
Gender, Female 34
Age =<50 years, females only 19
Age >50 years, females only 15
Race, White 61
Race, Black/African American 3
Race, Asian 1
Race, Other 1
Ethnicity, Hispanic/Latino 13
Ethnicity, Not Hispanic/Latino 37
Ethnicity, Not Reported 16
Body Mass Index <30% 22
Body Mass Index >=30% 44
11.Other Pre-specified Outcome
Title Baseline Demographic Characteristic (Weight) - Summary for ST + LT Treatment Period - Open-Label Cohort
Hide Description This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Mean (Standard Deviation)
Unit of Measure: kg
91.41  (20.65)
12.Other Pre-specified Outcome
Title Baseline Demographic Characteristic (Body Mass Index) - Summary for ST + LT Treatment Period - Open-Label Cohort
Hide Description This cohort represents a different population (screening A1C > 10.0% and ≤ 12.0%) than the double-blind cohort, and was presented separately in the study report.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Mean (Standard Deviation)
Unit of Measure: kg/m^2
31.73  (4.73)
13.Other Pre-specified Outcome
Title Overall Summary of Adverse Events During ST+LT Treatment Period
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.
Time Frame AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Measure Type: Number
Unit of Measure: participants
At Least 1 AE 89 94 87 77
At Least 1 Related AE 25 23 25 25
Deaths 0 0 0 1
At Least 1 SAE 11 18 9 11
At Least 1 Related SAE 0 1 0 0
Discontinuations Due to SAEs 6 2 3 1
Discontinuations Due to AEs 9 10 10 5
14.Other Pre-specified Outcome
Title Marked Laboratory Abnormalities - During ST + LT Treatment Period
Hide Description A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.
Time Frame Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.
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Hide Analysis Population Description
Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Measure Type: Number
Unit of Measure: participants
Hemoglobin < 8 g/dL (n=101, 105, 97, 93) 0 0 0 0
Hematocrit < 0.75 x pre-Rx (n=101, 105, 97, 93) 0 0 1 0
Platelets < 50 x 10^9 c/L (n=100, 104, 94, 93) 0 0 0 0
Platelets > 1.5 x ULN (n=100,104, 94, 93) 1 0 0 1
Leukocytes < 2 x 1000 c/µL (n=101, 105, 97, 93) 0 0 0 0
Neutrophils+Bands <1x1000 c/µL(n=101, 105, 97, 93) 0 0 1 0
Eosinophils >0.9x1000 c/µL (n=101, 105, 97, 93) 1 5 3 4
Lymphocytes <=0.75x1000 c/µL (n=101, 105, 97, 93) 4 2 2 1
ALP >3 x pre-Rx and >ULN (n=101,105, 97, 94) 0 0 0 0
ALP >1.5 x ULN (n=101, 105, 97, 94) 2 1 1 1
AST >3 x ULN (n=101, 105, 97, 94) 3 2 1 0
AST >5 x ULN (n=101, 105, 97, 94) 2 1 0 0
AST >10 x ULN (n=101, 105, 97, 94) 1 0 0 0
AST >20 x ULN (n=101, 105, 97, 94) 0 0 0 0
ALT >3 x ULN (n=101, 105, 97, 94) 3 2 0 1
ALT >5 x ULN (n=101, 105, 97, 94) 1 1 0 0
ALT >10 x ULN (n=101, 105, 97, 94) 1 0 0 0
ALT >20 x ULN (n=101, 105, 97, 94) 0 0 0 0
Bilirubin Total >2mg/dL (n=101, 105, 97, 94) 1 0 3 0
Bilirubin Total >1.5xULN (n=101, 105, 97, 94) 1 0 3 0
Bilirubin Total >2xULN (n=101, 105, 97, 94) 1 0 1 0
BUN >2 x pre-Rx and >ULN (n=101, 105, 97, 94) 1 3 1 0
Creatinine >2.5 mg/dL (n=101, 105, 97, 94) 1 0 0 0
Glucose, Serum Fasting < 50 mg/dL (n=0, 0, 0, 0) 0 0 0 0
Glucose, Serum Fasting > 500 mg/dL (n=0, 0, 0, 0) 0 0 0 0
Glucose, Serum Unspec. < 50 mg/dL (n=0,0,0,0) 0 0 0 0
Glucose, Serum Unspec. > 500 mg/dL (n=0,0,0,0) 0 0 0 0
Glucose, Plasma Fasting<50mg/dL(n=101, 104, 96,94) 1 0 1 2
Glucose,Plasma Fasting>500mg/dL(n=101, 104, 96,94) 0 0 0 0
Glucose, Plasma Unspec.<50mg/dL(n=102, 105, 98,95) 7 4 4 3
Glucose,Plasma Unspec.>500mg/dL(n=102, 105, 98,95) 0 1 0 2
Sodium,Serum Low (see above) (n=101, 105, 97, 94) 0 0 0 1
Sodium,Serum High(see above) (n=101, 105, 97, 94) 1 0 1 0
Potassium,Serum Low(see above)(n=101, 105, 97, 94) 0 0 0 0
Potassium, Serum High(see above)(n=101,105,97,94) 3 3 1 3
Chloride < 90 mEq/L (n=101, 105, 97, 94) 0 0 0 1
Chloride > 120 mEq/L (n=101, 105, 97, 94) 0 0 0 0
Albumin < 0.9 LLN (n=101, 105, 97, 94) 0 0 0 0
Creatine Kinase > 5 x ULN (n=101, 105, 97, 94) 2 4 1 4
Uric Acid > 1.5 x ULN (n=0, 0, 0, 0) 0 0 0 0
Protein Urine, >=2-4 (n=99, 103, 94, 92) 8 9 4 3
Blood Urine, >=2-4 (n=99, 103, 94, 92) 5 11 8 16
Red Blood Cells Urine >=2-4 (n=95, 97, 89, 88) 6 8 8 14
White Blood Cells Urine >=2-4 (n=95, 97, 89, 88) 13 19 15 12
15.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in Hemoglobin During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: g/dL
Baseline (BL) (Week 0) (n=102, 106, 98, 94) 14.49  (0.133) 14.45  (0.125) 14.47  (0.137) 14.50  (0.131)
Change from BL at Week 2 (n=95,100, 93, 87) -0.21  (0.069) -0.13  (0.065) -0.22  (0.075) -0.09  (0.078)
Change from BL at Week 4 (n=92, 99, 91, 91) -0.16  (0.071) -0.15  (0.082) -0.09  (0.069) 0.10  (0.063)
Change from BL at Week 6 (n=91, 96, 87, 82) -0.12  (0.069) -0.00  (0.074) -0.07  (0.073) 0.04  (0.069)
Change from BL at Week 8 (n=92, 90, 91, 79) -0.00  (0.068) 0.04  (0.080) -0.02  (0.071) 0.09  (0.074)
Change from BL at Week 10 (n=70, 76, 69, 63) 0.01  (0.082) -0.20  (0.096) -0.13  (0.086) 0.04  (0.097)
Change from BL at Week 12 (n=85, 88, 87, 82) -0.04  (0.074) -0.07  (0.079) -0.07  (0.083) 0.16  (0.075)
Change from BL at Week 14 (n=76, 80, 81, 75) -0.09  (0.090) -0.05  (0.078) -0.12  (0.085) -0.03  (0.083)
Change from BL at Week 16 (n=90, 91, 83, 71) -0.10  (0.087) 0.01  (0.078) 0.00  (0.087) 0.04  (0.084)
Change from BL at Week 18 (n=78, 75, 82, 71) -0.26  (0.083) -0.10  (0.079) -0.07  (0.092) -0.03  (0.099)
Change from BL at Week 20 (n=83, 80, 78, 72) -0.16  (0.079) -0.14  (0.093) -0.25  (0.081) -0.19  (0.086)
Change from BL at Week 22 (n=78, 74, 76, 65) -0.35  (0.075) -0.23  (0.092) -0.36  (0.087) -0.18  (0.102)
Change from BL at Week 24 (n=83, 82, 78, 74) -0.37  (0.079) -0.25  (0.080) -0.32  (0.078) -0.14  (0.100)
Change from BL at Week 30 (n=77, 78, 79, 67) -0.25  (0.081) -0.29  (0.097) -0.19  (0.086) -0.18  (0.101)
Change from BL at Week 37 (n=75, 73, 70, 62) -0.31  (0.094) -0.22  (0.087) -0.06  (0.090) -0.33  (0.093)
Change from BL at Week 50 (n=67, 71, 71, 61) -0.17  (0.082) 0.06  (0.103) -0.02  (0.107) -0.01  (0.100)
Change from BL at Week 63 (n=61, 66, 67, 55) -0.18  (0.112) -0.11  (0.096) 0.07  (0.102) 0.08  (0.139)
Change from BL at Week 76 (n=51, 59, 63, 49) -0.27  (0.125) -0.19  (0.119) -0.07  (0.102) -0.10  (0.117)
Change from BL at Week 89 (n=49, 58, 56, 42) -0.18  (0.109) -0.09  (0.097) -0.04  (0.103) -0.10  (0.109)
Change from BL at Week 102 (n=40, 49, 51, 40) -0.32  (0.132) -0.00  (0.129) -0.07  (0.121) -0.29  (0.131)
Change from BL at Week 115 (n=34, 43, 43, 35) -0.41  (0.132) -0.07  (0.137) -0.18  (0.147) -0.19  (0.116)
Change from BL at Week 128 (n=30, 40, 40, 30) -0.38  (0.125) -0.17  (0.128) -0.25  (0.132) -0.33  (0.124)
Change from BL at Week 141 (n=28, 39, 34, 28) -0.40  (0.125) -0.35  (0.156) -0.15  (0.169) -0.36  (0.104)
Change from BL at Week 154 (n=26, 34, 31, 24) -0.45  (0.160) -0.37  (0.186) -0.24  (0.166) -0.25  (0.130)
Change from BL at Week 167 (n=24, 33, 30, 26) -0.51  (0.178) -0.05  (0.161) -0.03  (0.170) -0.24  (0.148)
Change from BL at Week 180 (n=21, 28, 28, 26) -0.38  (0.178) -0.08  (0.176) -0.08  (0.167) -0.61  (0.169)
Change from BL at Week 193 (n=19, 26, 26, 23) -0.45  (0.212) -0.03  (0.190) -0.16  (0.178) -0.39  (0.175)
Change from BL at Week 206 (n=17, 22, 24, 21) -0.51  (0.221) -0.07  (0.195) 0.10  (0.124) -0.32  (0.174)
16.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in Hematocrit During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: percentage red blood cells
Baseline (BL) (Week 0) (n=102, 106, 98, 94) 42.5  (0.35) 42.8  (0.35) 42.7  (0.37) 42.8  (0.35)
Change from BL at Week 2 (n=95,100, 93, 87) -0.4  (0.22) -0.2  (0.20) -0.7  (0.21) -0.4  (0.23)
Change from BL at Week 4 (n=92, 99, 91, 91) -0.2  (0.21) -0.2  (0.24) -0.1  (0.22) 0.3  (0.21)
Change from BL at Week 6 (n=91, 96, 87, 82) 0.1  (0.19) 0.3  (0.24) 0.0  (0.24) 0.3  (0.25)
Change from BL at Week 8 (n=92, 90, 91, 79) 0.5  (0.22) 0.4  (0.27) 0.2  (0.20) 0.5  (0.25)
Change from BL at Week 10 (n=70, 76, 69, 63) 0.6  (0.25) -0.0  (0.31) -0.2  (0.24) 0.5  (0.32)
Change from BL at Week 12 (n=85, 88, 87, 82) 0.6  (0.25) 0.4  (0.26) 0.6  (0.26) 0.7  (0.25)
Change from BL at Week 14 (n=76, 80, 81, 75) 0.6  (0.27) 0.6  (0.27) 0.2  (0.27) 0.2  (0.26)
Change from BL at Week 16 (n=90. 91, 83, 71) 0.5  (0.24) 0.7  (0.26) 0.6  (0.25) 0.3  (0.30)
Change from BL at Week 18 (n=78, 75, 82, 71) 0.2  (0.27) 0.4  (0.29) 0.3  (0.24) 0.4  (0.30)
Change from BL at Week 20 (n=83, 80, 78, 72) 0.7  (0.25) 0.4  (0.31) 0.1  (0.26) 0.2  (0.27)
Change from BL at Week 22 (n=78, 74, 76, 65) 0.3  (0.27) 0.2  (0.32) -0.3  (0.26) 0.5  (0.32)
Change from BL at Week 24 (n=83, 82, 78, 74) 0.0  (0.24) 0.2  (0.28) -0.1  (0.24) 0.5  (0.32)
Change from BL at Week 30 (n=77, 78, 79, 67) 0.5  (0.30) -0.1  (0.36) 0.2  (0.30) 0.4  (0.35)
Change from BL at Week 37 (n=75, 73, 70, 62) 0.0  (0.30) -0.1  (0.27) 0.4  (0.29) -0.4  (0.33)
Change from BL at Week 50 (n=67, 71, 71, 61) 0.1  (0.29) 0.3  (0.33) 0.1  (0.34) 0.2  (0.27)
Change from BL at Week 63 (n=61, 66, 67, 55) 0.3  (0.34) 0.1  (0.31) 0.6  (0.34) 0.7  (0.43)
Change from BL at Week 76 (n=51, 59, 63, 49) 0.7  (0.39) 0.5  (0.40) 0.7  (0.35) 0.8  (0.34)
Change from BL at Week 89 (n=49, 58, 56, 42) 0.9  (0.37) 0.9  (0.34) 1.2  (0.35) 0.4  (0.36)
Change from BL at Week 102 (n=40, 49, 51, 40) -0.2  (0.37) 0.5  (0.40) -0.0  (0.34) -0.7  (0.36)
Change from BL at Week 115 (n=34, 43, 43, 35) -0.0  (0.42) 0.6  (0.42) 0.2  (0.46) 0.2  (0.40)
Change from BL at Week 128 (n=30, 40, 40, 30) 0.2  (0.42) 0.3  (0.43) 0.0  (0.43) -0.1  (0.42)
Change from BL at Week 141 (n=28, 39, 34, 28) -0.1  (0.42) -0.1  (0.48) 0.2  (0.50) -0.2  (0.41)
Change from BL at Week 154 (n=26, 34, 31, 24) -0.8  (0.45) -0.8  (0.43) -1.0  (0.51) -0.3  (0.43)
Change from BL at Week 167 (n=24, 33, 30, 26) -0.1  (0.53) 0.2  (0.46) 0.2  (0.56) -0.4  (0.48)
Change from BL at Week 180 (n=21, 28, 28, 26) 1.1  (0.55) 0.6  (0.58) 1.0  (0.53) -0.5  (0.57)
Change from BL at Week 193 (n=19, 26, 26, 23) 0.6  (0.65) 1.1  (0.55) 0.5  (0.61) -0.0  (0.59)
Change from BL at Week 206 (n=17, 22, 24, 21) -0.4  (0.54) 0.2  (0.52) 0.2  (0.42) -0.5  (0.52)
17.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in Red Blood Cell Counts (x 10^6 c/µL) During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: x 10^6 c/µL
Baseline (BL) (Week 0) (n=102, 106, 98, 94) 4.80  (0.038) 4.80  (0.042) 4.82  (0.039) 4.82  (0.043)
Change from BL at Week 2 (n=95,100, 93, 87 -0.06  (0.021) -0.04  (0.021) -0.08  (0.023) -0.05  (0.023)
Change from BL at Week 4 (n=92, 99, 91, 91) -0.01  (0.023) -0.04  (0.026) -0.02  (0.022) 0.04  (0.020)
Change from BL at Week 6 (n=91, 96, 87, 82) 0.00  (0.022) 0.02  (0.024) 0.00  (0.026) 0.02  (0.023)
Change from BL at Week 8 (n=92, 90, 91, 79) 0.05  (0.020) 0.03  (0.026) 0.03  (0.023) 0.05  (0.023)
Change from BL at Week 10 (n=70, 76, 69, 63) 0.05  (0.026) -0.03  (0.033) -0.02  (0.026) 0.07  (0.032)
Change from BL at Week 12 (n=85, 88, 87, 82) 0.05  (0.025) 0.03  (0.029) 0.07  (0.025) 0.08  (0.026)
Change from BL at Week 14 (n=76, 80, 81, 75) 0.05  (0.027) 0.03  (0.029) 0.04  (0.030) 0.04  (0.025)
Change from BL at Week 16 (n=90, 91, 83, 71) 0.06  (0.027) 0.08  (0.028) 0.08  (0.027) 0.06  (0.028)
Change from BL at Week 18 (n=78, 75, 82, 71) 0.01  (0.024) 0.04  (0.029) 0.05  (0.028) 0.04  (0.030)
Change from BL at Week 20 (n=83, 80, 78, 72) 0.03  (0.023) 0.02  (0.031) 0.01  (0.025) -0.01  (0.026)
Change from BL at Week 22 (n=78, 74, 76, 65) -0.01  (0.023) -0.01  (0.033) -0.05  (0.029) -0.01  (0.032)
Change from BL at Week 24 (n=83, 82, 78, 74) -0.04  (0.024) -0.04  (0.029) -0.03  (0.026) -0.01  (0.031)
Change from BL at Week 30 (n=77, 78, 79, 67) 0.00  (0.027) -0.07  (0.035) -0.01  (0.031) -0.03  (0.034)
Change from BL at Week 37 (n=75, 73, 70, 62) -0.04  (0.028) -0.04  (0.027) 0.04  (0.031) -0.09  (0.033)
Change from BL at Week 50 (n=67, 71, 71, 61) -0.02  (0.027) 0.04  (0.031) 0.02  (0.034) 0.01  (0.026)
Change from BL at Week 63 (n=61, 66, 67, 55) 0.00  (0.032) -0.01  (0.028) 0.08  (0.034) 0.05  (0.045)
Change from BL at Week 76 (n=51, 59, 63, 49) -0.07  (0.037) -0.07  (0.038) 0.00  (0.036) -0.03  (0.037)
Change from BL at Week 89 (n=49, 58, 56, 42) -0.04  (0.034) -0.06  (0.028) -0.01  (0.035) -0.07  (0.031)
Change from BL at Week 102 (n=40, 49, 51, 40) -0.10  (0.040) -0.03  (0.043) -0.03  (0.037) -0.13  (0.037)
Change from BL at Week 115 (n=34, 43, 43, 35) -0.04  (0.039) -0.01  (0.043) -0.02  (0.044) -0.06  (0.033)
Change from BL at Week 128 (n=30, 40, 40, 30) -0.05  (0.037) -0.07  (0.039) -0.04  (0.048) -0.10  (0.039)
Change from BL at Week 141 (n=28, 39, 34, 28) -0.10  (0.037) -0.13  (0.048) -0.02  (0.052) -0.11  (0.041)
Change from BL at Week 154 (n=26, 35, 31, 24) -0.13  (0.037) -0.13  (0.045) -0.08  (0.054) -0.09  (0.045)
Change from BL at Week 167 (n=24, 33, 30, 26) -0.11  (0.052) -0.04  (0.049) -0.01  (0.057) -0.10  (0.044)
Change from BL at Week 180 (n=21, 28, 28, 26) -0.05  (0.041) -0.08  (0.059) -0.01  (0.054) -0.17  (0.056)
Change from BL at Week 193 (n=19, 26, 26, 23) -0.05  (0.054) -0.06  (0.061) -0.02  (0.057) -0.10  (0.062)
Change from BL at Week 206 (n=17, 22, 24, 21) -0.03  (0.064) -0.06  (0.058) 0.06  (0.043) -0.08  (0.055)
18.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in Platelet Counts (x 10^9 c/L) During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: x 10^9 c/L
Baseline (BL) (Week 0) (n=101, 106, 96, 94) 251.1  (6.33) 253.1  (5.93) 261.6  (6.71) 259.8  (6.25)
Change from BL at Week 2 (n=92, 96, 85, 82) 1.8  (3.40) 4.4  (2.82) 2.2  (3.72) 9.5  (3.47)
Change from BL at Week 4 (n=88, 97, 90, 90) 11.2  (3.39) 8.6  (3.41) 5.6  (3.11) 11.3  (2.94)
Change from BL at Week 6 (n=88, 93, 84, 81) 4.3  (2.85) 4.3  (3.53) -0.2  (3.39) 9.5  (3.05)
Change from BL at Week 8 (n=86, 85, 86, 77) 0.4  (3.21) 1.0  (3.13) -4.3  (2.94) 4.0  (4.26)
Change from BL at Week 10 (n=68, 75, 67, 62) -0.8  (3.87) 3.0  (3.99) -4.4  (4.44) 7.1  (3.53)
Change from BL at Week 12 (n=83, 84, 85, 82) -6.3  (3.58) -1.3  (3.85) -4.8  (4.14) 4.0  (3.21)
Change from BL at Week 14 (n=72, 79, 77, 74) 1.2  (3.91) 3.2  (4.75) -3.7  (4.21) 5.2  (3.59)
Change from BL at Week 16 (n=86, 88, 81, 69) -2.3  (3.73) 1.1  (3.66) -6.0  (3.74) 3.2  (3.72)
Change from BL at Week 18 (n=77, 71, 79, 70) -1.1  (3.93) 2.0  (4.06) -2.7  (3.63) 5.8  (3.79)
Change from BL at Week 20 (n=78, 78, 72, 70) -1.9  (3.87) -4.8  (4.39) -8.3  (3.94) -1.3  (3.38)
Change from BL at Week 22 (n=74, 72, 73, 62) 0.3  (4.64) -2.5  (3.91) -5.4  (4.01) 5.0  (3.48)
Change from BL at Week 24 (n=80, 76, 73, 72) -7.1  (3.94) -6.0  (4.00) -15.5  (4.54) -3.0  (3.66)
Change from BL at Week 30 (n=73, 74, 74, 67) -2.0  (5.66) -3.3  (4.37) -9.9  (4.34) 4.5  (4.08)
Change from BL at Week 37 (n=70, 68, 66, 59) -14.3  (3.85) -8.1  (4.71) -15.6  (3.93) 0.1  (4.81)
Change from BL at Week 50 (n=66, 67, 66, 59) -2.5  (4.25) -5.6  (4.39) -11.5  (3.76) 6.6  (6.29)
Change from BL at Week 63 (n=59, 64, 65, 54) -3.1  (4.57) -3.4  (4.24) -6.3  (4.23) 10.2  (5.37)
Change from BL at Week 76 (n=50, 58, 61, 49) -2.0  (5.64) -1.5  (4.56) -6.0  (3.68) 1.2  (4.88)
Change from BL at Week 89 (n=47, 56, 54, 42) 3.5  (5.29) 1.9  (5.02) -6.7  (3.83) 2.7  (4.97)
Change from BL at Week 102 (n=39, 47, 49, 39) 3.2  (7.75) -2.3  (5.34) -4.8  (3.65) 9.7  (7.21)
Change from BL at Week 115 (n=33, 41, 41, 34) 5.0  (8.04) -8.8  (4.96) -12.0  (4.23) 9.2  (7.57)
Change from BL at Week 128 (n=30, 38, 39, 30) 3.8  (5.74) -2.1  (5.39) -2.6  (5.04) 2.6  (7.91)
Change from BL at Week 141 (n=27, 39, 33, 27) -1.1  (5.34) -4.6  (5.16) -0.3  (4.73) -1.3  (8.24)
Change from BL at Week 154 (n=25, 35, 31, 23) 5.0  (6.95) 5.8  (7.20) -2.9  (5.25) 8.8  (13.59)
Change from BL at Week 167 (n=22, 32, 28, 26) -18.0  (6.71) -0.1  (6.99) -14.6  (6.21) 4.3  (8.63)
Change from BL at Week 180 (n=20, 27, 27, 25) -11.1  (6.57) -24.0  (6.18) -17.3  (6.54) 4.0  (10.72)
Change from BL at Week 193 (n=17, 25, 25, 22) -13.6  (8.11) -13.4  (9.58) -13.4  (6.00) -12.0  (7.27)
Change from BL at Week 206 (n=15, 21, 23, 21) -2.6  (10.45) -18.7  (9.01) 6.2  (9.35) -6.1  (11.49)
19.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in White Blood Cell Counts (x 10^3 c/µL) During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: x 10^3 c/µL
Baseline (BL) (Week 0) (n=102, 106, 98, 94) 6.71  (0.179) 6.75  (0.198) 6.82  (0.155) 6.79  (0.182)
Change from BL at Week 2 (n=95, 99, 92, 86) -0.11  (0.136) 0.05  (0.132) -0.14  (0.113) -0.23  (0.156)
Change from BL at Week 4 (n=92, 99, 90, 90) 0.06  (0.132) 0.05  (0.125) -0.16  (0.132) 0.17  (0.137)
Change from BL at Week 6 (n=89, 95, 87, 82) 0.01  (0.115) 0.10  (0.126) -0.18  (0.128) 0.09  (0.172)
Change from BL at Week 8 (n=91, 89, 90, 79) -0.02  (0.132) 0.18  (0.144) -0.17  (0.121) 0.16  (0.149)
Change from BL at Week 10 (n=68, 76, 69, 63) 0.32  (0.168) 0.55  (0.169) 0.12  (0.162) 0.53  (0.208)
Change from BL at Week 12 (n=83, 88, 87, 82) -0.00  (0.148) 0.09  (0.155) 0.05  (0.145) 0.26  (0.163)
Change from BL at Week 14 (n=76, 78, 80, 75) 0.33  (0.196) 0.71  (0.166) 0.22  (0.134) 0.56  (0.192)
Change from BL at Week 16 (n=90, 91, 83, 71) 0.24  (0.146) 0.54  (0.148) 0.04  (0.138) 0.19  (0.163)
Change from BL at Week 18 (n=78, 75, 82, 71) 0.37  (0.166) 0.82  (0.172) 0.42  (0.142) 0.32  (0.185)
Change from BL at Week 20 (n=83, 79, 78, 72) 0.29  (0.150) 0.29  (0.163) 0.01  (0.140) 0.02  (0.154)
Change from BL at Week 22 (n=77, 74, 76, 65) 0.66  (0.184) 0.72  (0.178) 0.44  (0.175) 0.45  (0.163)
Change from BL at Week 24 (n=83, 82, 78, 74) 0.10  (0.149) 0.47  (0.265) 0.08  (0.158) -0.06  (0.142)
Change from BL at Week 30 (n=77, 78, 79, 67) 0.15  (0.148) 0.33  (0.202) 0.28  (0.167) -0.03  (0.129)
Change from BL at Week 37 (n=74, 73, 70, 62) 0.21  (0.163) 0.42  (0.204) 0.12  (0.189) 0.14  (0.159)
Change from BL at Week 50 (n=67, 69, 71, 61) 0.01  (0.168) 0.33  (0.216) -0.03  (0.149) 0.29  (0.186)
Change from BL at Week 63 (n=60, 66, 67, 55) 0.12  (0.176) 0.20  (0.221) -0.04  (0.180) 0.06  (0.176)
Change from BL at Week 76 (n=51, 58, 63, 49) 0.03  (0.185) 0.23  (0.259) -0.07  (0.158) -0.20  (0.169)
Change from BL at Week 89 (n=48, 58, 56, 42) 0.51  (0.232) 0.17  (0.246) -0.10  (0.152) -0.18  (0.232)
Change from BL at Week 102 (n=39, 47, 51, 40) 0.16  (0.218) 0.44  (0.258) 0.10  (0.129) -0.09  (0.208)
Change from BL at Week 115 (n=34, 43, 42, 34) 0.24  (0.235) 0.93  (0.252) 0.11  (0.210) 0.44  (0.286)
Change from BL at Week 128 (n=30, 40, 40, 29) 0.58  (0.227) 0.66  (0.314) 0.44  (0.221) 0.22  (0.286)
Change from BL at Week 141 (n=28, 39, 34, 28) 0.35  (0.183) 0.78  (0.303) 0.44  (0.199) 0.51  (0.214)
Change from BL at Week 154 (n=26, 34, 31, 24) 0.12  (0.228) 0.44  (0.327) 0.30  (0.212) 0.38  (0.217)
Change from BL at Week 167 (n=24, 33, 30, 25) -0.22  (0.233) 0.44  (0.341) 0.27  (0.209) 0.35  (0.180)
Change from BL at Week 180 (n=21, 28, 28, 26) 0.13  (0.233) 0.30  (0.379) 0.59  (0.263) 0.65  (0.267)
Change from BL at Week 193 (n=19, 26, 26, 23) 0.34  (0.220) 0.02  (0.403) 0.60  (0.205) 0.19  (0.157)
Change from BL at Week 206 (n=17, 22, 23, 21) 0.01  (0.199) 0.55  (0.420) 1.01  (0.303) 0.38  (0.284)
20.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in Absolute Neutrophil Counts (x 10^3 c/µL) During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: x 10^3 c/µL
Baseline (BL) (Week 0) (n=102, 106, 98, 94) 4.00  (0.141) 3.98  (0.142) 4.16  (0.137) 4.01  (0.148)
Change from BL at Week 2 (n=95, 99, 92, 86) -0.06  (0.122) 0.11  (0.117) 0.00  (0.101) -0.07  (0.131)
Change from BL at Week 4 (n=91, 99, 90, 90) 0.09  (0.114) 0.16  (0.103) 0.05  (0.121) 0.23  (0.120)
Change from BL at Week 6 (n=89, 95, 87, 82) 0.01  (0.105) 0.19  (0.097) 0.04  (0.114) 0.17  (0.150)
Change from BL at Week 8 (n=91, 88, 90, 79) 0.02  (0.110) 0.27  (0.131) 0.03  (0.096) 0.19  (0.126)
Change from BL at Week 10 (n=68, 76, 69, 63) 0.18  (0.135) 0.48  (0.145) 0.17  (0.139) 0.45  (0.169)
Change from BL at Week 12 (n=83, 88, 87, 82) 0.01  (0.135) 0.21  (0.130) 0.18  (0.115) 0.30  (0.139)
Change from BL at Week 14 (n=76, 77, 80, 75) 0.07  (0.158) 0.64  (0.119) 0.17  (0.115) 0.46  (0.161)
Change from BL at Week 16 (n=90, 91, 83, 71) 0.17  (0.116) 0.49  (0.132) 0.16  (0.132) 0.18  (0.140)
Change from BL at Week 18 (n=78, 75, 82, 71) 0.23  (0.120) 0.67  (0.149) 0.32  (0.130) 0.21  (0.148)
Change from BL at Week 20 (n=83, 79, 78, 72) 0.19  (0.131) 0.32  (0.141) 0.07  (0.130) 0.15  (0.127)
Change from BL at Week 22 (n=77, 74, 75, 65) 0.44  (0.155) 0.58  (0.160) 0.44  (0.153) 0.32  (0.130)
Change from BL at Week 24 (n=83, 81, 78, 74) 0.09  (0.124) 0.57  (0.263) 0.16  (0.130) -0.03  (0.115)
Change from BL at Week 30 (n=76, 78, 79, 67) 0.04  (0.124) 0.29  (0.155) 0.32  (0.122) 0.00  (0.114)
Change from BL at Week 37 (n=74, 72, 70, 60) 0.13  (0.146) 0.42  (0.171) 0.24  (0.165) 0.20  (0.137)
Change from BL at Week 50 (n=67, 69, 71, 61) 0.03  (0.144) 0.40  (0.182) 0.19  (0.128) 0.27  (0.161)
Change from BL at Week 63 (n=60, 66, 67, 55) 0.11  (0.140) 0.25  (0.176) 0.08  (0.168) 0.16  (0.152)
Change from BL at Week 76 (n=51, 58, 63, 49) 0.05  (0.161) 0.33  (0.204) 0.08  (0.146) -0.01  (0.140)
Change from BL at Week 89 (n=48, 58, 56, 42) 0.58  (0.208) 0.18  (0.178) 0.05  (0.136) 0.01  (0.185)
Change from BL at Week 102 (n=39, 47, 50, 40) 0.19  (0.212) 0.43  (0.215) 0.24  (0.114) 0.01  (0.176)
Change from BL at Week 115 (n=34, 43, 42, 34) 0.28  (0.219) 0.81  (0.165) 0.29  (0.178) 0.42  (0.223)
Change from BL at Week 128 (n=30, 40, 40, 29) 0.61  (0.202) 0.59  (0.244) 0.56  (0.209) 0.22  (0.245)
Change from BL at Week 141 (n=28, 38, 34, 28) 0.41  (0.168) 0.80  (0.254) 0.45  (0.161) 0.40  (0.198)
Change from BL at Week 154 (n=26, 33, 31, 24) 0.25  (0.223) 0.39  (0.225) 0.47  (0.162) 0.41  (0.184)
Change from BL at Week 167 (n=24, 33, 30, 25) -0.04  (0.211) 0.56  (0.239) 0.27  (0.193) 0.33  (0.176)
Change from BL at Week 180 (n=21, 28, 28, 26) 0.23  (0.220) 0.50  (0.293) 0.55  (0.200) 0.51  (0.271)
Change from BL at Week 193 (n=19, 25, 26, 23) 0.34  (0.181) 0.08  (0.277) 0.51  (0.166) -0.01  (0.130)
Change from BL at Week 206 (n=17, 22, 23, 21) 0.15  (0.218) 0.63  (0.389) 0.90  (0.284) 0.31  (0.235)
21.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in Absolute Lymphocyte Counts (x 10^3 c/µL) During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: x 10^3 c/µL
Baseline (BL) (Week 0) (n=102, 106, 98, 94) 2.16  (0.062) 2.21  (0.071) 2.14  (0.063) 2.22  (0.063)
Change from BL at Week 2 (n=95, 99, 92, 86) -0.04  (0.052) -0.10  (0.045) -0.11  (0.046) -0.13  (0.049)
Change from BL at Week 4 (n=91, 99, 90, 90) -0.03  (0.056) -0.12  (0.046) -0.18  (0.046) -0.04  (0.040)
Change from BL at Week 6 (n=89, 95, 87, 82) -0.04  (0.049) -0.09  (0.057) -0.23  (0.047) -0.09  (0.048)
Change from BL at Week 8 (n=91, 88, 90, 79) -0.07  (0.049) -0.11  (0.049) -0.20  (0.048) -0.00  (0.053)
Change from BL at Week 10 (n=68, 76, 69, 63) 0.07  (0.069) 0.02  (0.055) -0.10  (0.053) 0.05  (0.068)
Change from BL at Week 12 (n=83, 88, 87, 82) -0.06  (0.049) -0.12  (0.044) -0.16  (0.052) -0.02  (0.058)
Change from BL at Week 14 (n=76, 77, 80, 75) 0.20  (0.071) 0.08  (0.085) -0.01  (0.052) 0.06  (0.058)
Change from BL at Week 16 (n=90, 91, 83, 71) 0.03  (0.065) 0.01  (0.057) -0.11  (0.049) 0.01  (0.061)
Change from BL at Week 18 (n=78, 75, 82, 71) 0.11  (0.079) 0.13  (0.064) 0.01  (0.064) 0.08  (0.069)
Change from BL at Week 20 (n=83, 79, 78, 72) 0.08  (0.065) -0.02  (0.064) -0.10  (0.058) -0.11  (0.052)
Change from BL at Week 22 (n=77, 74, 75, 65) 0.16  (0.069) 0.13  (0.083) -0.07  (0.060) 0.09  (0.067)
Change from BL at Week 24 (n=83, 81, 78, 74) -0.00  (0.068) -0.07  (0.071) -0.13  (0.054) -0.01  (0.059)
Change from BL at Week 30 (n=76, 78, 79, 67) 0.08  (0.066) -0.00  (0.060) -0.09  (0.063) -0.03  (0.059)
Change from BL at Week 37 (n=74, 72, 70, 60) 0.05  (0.067) 0.02  (0.064) -0.17  (0.056) -0.08  (0.066)
Change from BL at Week 50 (n=67, 69, 71, 61) -0.06  (0.071) -0.09  (0.069) -0.25  (0.051) -0.03  (0.059)
Change from BL at Week 63 (n=60, 66, 67, 55) -0.06  (0.077) -0.10  (0.063) -0.19  (0.070) -0.16  (0.063)
Change from BL at Week 76 (n=51, 58, 63, 49) -0.10  (0.086) -0.09  (0.082) -0.18  (0.054) -0.20  (0.072)
Change from BL at Week 89 (n=49, 58, 56, 42) -0.12  (0.087) -0.02  (0.080) -0.19  (0.054) -0.23  (0.083)
Change from BL at Week 102 (n=39, 48, 51, 40) -0.17  (0.081) -0.07  (0.086) -0.23  (0.056) -0.16  (0.071)
Change from BL at Week 115 (n=34, 43, 43, 35) -0.15  (0.080) -0.00  (0.103) -0.21  (0.068) -0.10  (0.100)
Change from BL at Week 128 (n=30, 40, 40, 30) -0.12  (0.106) -0.00  (0.105) -0.16  (0.068) -0.06  (0.094)
Change from BL at Week 141 (n=28, 38, 34, 28) -0.13  (0.089) -0.03  (0.083) -0.10  (0.079) 0.00  (0.086)
Change from BL at Week 154 (n=26, 33, 31, 24) -0.23  (0.096) 0.04  (0.128) -0.23  (0.101) -0.14  (0.096)
Change from BL at Week 167 (n=24, 33, 30, 25) -0.23  (0.096) -0.13  (0.118) -0.11  (0.090) -0.16  (0.084)
Change from BL at Week 180 (n=21, 28, 28, 26) -0.15  (0.107) -0.22  (0.130) -0.06  (0.105) -0.05  (0.102)
Change from BL at Week 193 (n=19, 25, 26, 23) -0.06  (0.094) -0.09  (0.151) -0.04  (0.092) 0.01  (0.101)
Change from BL at Week 206 (n=17, 22, 23, 21) -0.17  (0.126) -0.14  (0.105) -0.05  (0.094) -0.08  (0.113)
22.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in Absolute Monocyte Counts (x 10^3 c/µL) During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: x 10^3 c/µL
Baseline (BL) (Week 0) (n=102, 106, 98, 94) 0.31  (0.016) 0.34  (0.017) 0.32  (0.016) 0.32  (0.015)
Change from BL at Week 2 (n=95, 99, 92, 86) 0.01  (0.015) 0.01  (0.017) -0.05  (0.021) -0.01  (0.018)
Change from BL at Week 4 (n=91, 99, 90, 90) 0.05  (0.015) 0.00  (0.014) -0.01  (0.020) 0.01  (0.015)
Change from BL at Week 6 (n=89, 95, 87, 82) 0.05  (0.017) -0.01  (0.017) -0.01  (0.019) 0.02  (0.019)
Change from BL at Week 8 (n=91, 88, 90, 79) 0.03  (0.016) 0.03  (0.018) -0.01  (0.017) -0.02  (0.018)
Change from BL at Week 10 (n=68, 76, 69, 63) 0.08  (0.020) 0.04  (0.021) 0.04  (0.021) 0.03  (0.024)
Change from BL at Week 12 (n=83, 88, 87, 82) 0.05  (0.017) 0.00  (0.018) 0.00  (0.019) 0.01  (0.018)
Change from BL at Week 14 (n=76, 77, 80, 75) 0.09  (0.019) 0.06  (0.022) 0.03  (0.021) 0.04  (0.021)
Change from BL at Week 16 (n=90, 91, 83, 71) 0.06  (0.018) 0.04  (0.019) 0.04  (0.019) 0.01  (0.017)
Change from BL at Week 18 (n=78, 75, 82, 71) 0.06  (0.018) 0.05  (0.025) 0.06  (0.018) 0.04  (0.021)
Change from BL at Week 20 (n=83, 79, 78, 72) 0.04  (0.017) 0.02  (0.018) 0.04  (0.021) 0.01  (0.022)
Change from BL at Week 22 (n=77, 74, 75, 65) 0.08  (0.023) 0.05  (0.017) 0.06  (0.021) 0.05  (0.021)
Change from BL at Week 24 (n=83, 81, 78, 74) 0.04  (0.019) 0.01  (0.019) 0.03  (0.019) 0.03  (0.019)
Change from BL at Week 30 (n=76, 78, 79, 67) 0.05  (0.020) 0.03  (0.022) 0.04  (0.021) 0.03  (0.018)
Change from BL at Week 37 (n=74, 72, 70, 60) 0.06  (0.022) 0.02  (0.022) 0.04  (0.020) 0.00  (0.020)
Change from BL at Week 50 (n=67, 69, 71, 61) 0.07  (0.021) 0.03  (0.020) 0.05  (0.022) 0.06  (0.018)
Change from BL at Week 63 (n=60, 66, 67, 55) 0.08  (0.021) 0.05  (0.022) 0.07  (0.026) 0.07  (0.019)
Change from BL at Week 76 (n=51, 58, 63, 49) 0.12  (0.026) 0.04  (0.028) 0.06  (0.024) 0.05  (0.020)
Change from BL at Week 89 (n=48, 58, 56, 42) 0.11  (0.023) 0.03  (0.026) 0.08  (0.022) 0.05  (0.028)
Change from BL at Week 102 (n=39, 47, 50, 40) 0.14  (0.025) 0.04  (0.028) 0.09  (0.028) 0.07  (0.025)
Change from BL at Week 115 (n=34, 43, 42, 34) 0.12  (0.033) 0.05  (0.026) 0.06  (0.029) 0.13  (0.030)
Change from BL at Week 128 (n=30, 40, 40, 29) 0.12  (0.031) 0.04  (0.031) 0.07  (0.026) 0.07  (0.022)
Change from BL at Week 141 (n=28, 38, 34, 28) 0.08  (0.029) 0.02  (0.030) 0.10  (0.028) 0.10  (0.024)
Change from BL at Week 154 (n=26, 33, 31, 24) 0.10  (0.025) 0.05  (0.037) 0.06  (0.035) 0.08  (0.022)
Change from BL at Week 167 (n=24, 33, 30, 25) 0.07  (0.029) 0.04  (0.036) 0.10  (0.036) 0.11  (0.023)
Change from BL at Week 180 (n=21, 28, 28, 26) 0.08  (0.028) 0.04  (0.041) 0.11  (0.040) 0.11  (0.021)
Change from BL at Week 193 (n=19, 25, 26, 23) 0.09  (0.039) 0.04  (0.044) 0.11  (0.036) 0.13  (0.023)
Change from BL at Week 206 (n=17, 22, 23, 21) 0.05  (0.033) 0.05  (0.034) 0.13  (0.042) 0.09  (0.023)
23.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in Absolute Basophil Counts (x 10^3 c/µL) During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: x 10^3 c/µL
Baseline (BL) (Week 0) (n=102, 106, 98, 94) 0.01  (0.003) 0.02  (0.004) 0.02  (0.004) 0.02  (0.004)
Change from BL at Week 2 (n=95, 99, 92, 86) 0.00  (0.004) -0.01  (0.004) -0.01  (0.004) 0.00  (0.005)
Change from BL at Week 4 (n=91, 99, 90, 90) 0.00  (0.004) -0.01  (0.004) -0.01  (0.003) -0.00  (0.005)
Change from BL at Week 6 (n=89, 95, 87, 82) 0.01  (0.005) -0.01  (0.004) -0.01  (0.004) -0.01  (0.005)
Change from BL at Week 8 (n=91, 88, 90, 79) 0.00  (0.003) -0.00  (0.005) -0.01  (0.004) -0.01  (0.005)
Change from BL at Week 10 (n=68, 76, 69, 63) 0.00  (0.004) -0.01  (0.004) -0.01  (0.004) -0.01  (0.005)
Change from BL at Week 12 (n=83, 88, 87, 82) -0.00  (0.004) -0.01  (0.005) -0.00  (0.004) -0.00  (0.005)
Change from BL at Week 14 (n=76, 77, 80, 75) 0.00  (0.004) 0.00  (0.006) -0.01  (0.004) -0.00  (0.005)
Change from BL at Week 16 (n=90, 91, 83, 71) 0.00  (0.004) -0.00  (0.005) -0.01  (0.003) -0.01  (0.006)
Change from BL at Week 18 (n=78, 75, 82, 71) 0.00  (0.004) 0.00  (0.005) -0.00  (0.006) -0.01  (0.005)
Change from BL at Week 20 (n=83, 79, 78, 72) 0.01  (0.004) -0.01  (0.005) -0.01  (0.004) -0.00  (0.005)
Change from BL at Week 22 (n=77, 74, 75, 65) 0.01  (0.004) -0.00  (0.005) 0.00  (0.013) -0.00  (0.006)
Change from BL at Week 24 (n=83, 81, 78, 74) 0.00  (0.005) -0.01  (0.004) -0.01  (0.005) -0.01  (0.006)
Change from BL at Week 30 (n=76, 78, 79, 67) 0.00  (0.004) 0.01  (0.006) -0.01  (0.005) 0.01  (0.006)
Change from BL at Week 37 (n=74, 72, 70, 60) 0.00  (0.004) 0.01  (0.006) 0.00  (0.005) 0.00  (0.007)
Change from BL at Week 50 (n=67, 69, 71, 61) 0.02  (0.004) 0.01  (0.006) 0.01  (0.005) 0.02  (0.005)
Change from BL at Week 63 (n=60, 66, 67, 55) 0.02  (0.005) 0.01  (0.005) 0.02  (0.006) 0.02  (0.004)
Change from BL at Week 76 (n=51, 58, 63, 49) 0.02  (0.004) 0.01  (0.005) 0.02  (0.005) 0.01  (0.005)
Change from BL at Week 89 (n=48, 58, 56, 42) 0.02  (0.006) 0.02  (0.006) 0.02  (0.005) 0.02  (0.006)
Change from BL at Week 102 (n=39, 47, 50, 40) 0.02  (0.007) 0.02  (0.005) 0.02  (0.005) 0.02  (0.007)
Change from BL at Week 115 (n=34, 43, 42, 34) 0.02  (0.006) 0.03  (0.007) 0.01  (0.007) 0.03  (0.008)
Change from BL at Week 128 (n=30, 40, 40, 29) 0.03  (0.008) 0.03  (0.007) 0.01  (0.006) 0.03  (0.008)
Change from BL at Week 141 (n=28, 38, 34, 28) 0.02  (0.008) 0.02  (0.007) 0.01  (0.007) 0.02  (0.009)
Change from BL at Week 154 (n=26, 33, 31, 24) 0.03  (0.008) 0.02  (0.006) 0.02  (0.009) 0.01  (0.010)
Change from BL at Week 167 (n=24, 33, 30, 25) 0.02  (0.009) 0.01  (0.008) 0.01  (0.008) 0.02  (0.008)
Change from BL at Week 180 (n=21, 28, 28, 26) 0.01  (0.007) 0.02  (0.007) 0.00  (0.007) 0.02  (0.009)
Change from BL at Week 193 (n=19, 25, 26, 23) 0.01  (0.010) 0.01  (0.009) 0.01  (0.008) 0.02  (0.008)
Change from BL at Week 206 (n=17, 22, 23, 21) 0.00  (0.013) 0.02  (0.010) 0.01  (0.010) 0.01  (0.009)
24.Other Pre-specified Outcome
Title Baseline and Changes From Baseline in Absolute Eosinophil Counts (x 10^3 c/µL) During the ST + LT Period
Hide Description [Not Specified]
Time Frame Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: x 10^3 c/µL
Baseline (BL) (Week 0) (n=102, 106, 98, 94) 0.18  (0.012) 0.20  (0.015) 0.20  (0.012) 0.20  (0.016)
Change from BL at Week 2 (n=95, 99, 92, 86) -0.01  (0.008) 0.01  (0.011) -0.02  (0.009) -0.02  (0.013)
Change from BL at Week 4 (n=91, 99, 90, 90) -0.02  (0.011) -0.01  (0.012) -0.01  (0.011) -0.02  (0.012)
Change from BL at Week 6 (n=89, 95, 87, 82) 0.01  (0.009) -0.01  (0.012) -0.02  (0.011) -0.02  (0.014)
Change from BL at Week 8 (n=91, 88, 90, 79) 0.00  (0.011) -0.01  (0.014) -0.02  (0.012) -0.01  (0.015)
Change from BL at Week 10 (n=68, 76, 69, 63) -0.01  (0.014) -0.02  (0.015) -0.02  (0.013) 0.01  (0.015)
Change from BL at Week 12 (n=83, 88, 87, 82) 0.00  (0.024) -0.02  (0.014) -0.01  (0.015) -0.02  (0.013)
Change from BL at Week 14 (n=76, 77, 80, 75) -0.01  (0.015) -0.01  (0.017) -0.01  (0.019) -0.01  (0.017)
Change from BL at Week 16 (n=90, 91, 83, 71) -0.02  (0.010) -0.02  (0.014) -0.03  (0.014) -0.00  (0.018)
Change from BL at Week 18 (n=78, 75, 82, 71) -0.02  (0.011) -0.02  (0.018) -0.03  (0.013) 0.00  (0.020)
Change from BL at Week 20 (n=83, 79, 78, 72) -0.02  (0.012) -0.03  (0.015) -0.04  (0.012) -0.03  (0.016)
Change from BL at Week 22 (n=77, 74, 75, 65) -0.00  (0.015) -0.03  (0.013) -0.04  (0.012) -0.02  (0.016)
Change from BL at Week 24 (n=83, 81, 78, 74) -0.02  (0.013) -0.03  (0.015) -0.03  (0.011) -0.04  (0.016)
Change from BL at Week 30 (n=76, 78, 79, 67) -0.03  (0.013) -0.03  (0.017) -0.02  (0.011) -0.03  (0.016)
Change from BL at Week 37 (n=74, 72, 70, 60) -0.03  (0.010) -0.01  (0.019) -0.04  (0.012) -0.02  (0.020)
Change from BL at Week 50 (n=67, 69, 71, 61) -0.03  (0.013) -0.01  (0.019) -0.02  (0.011) -0.01  (0.018)
Change from BL at Week 63 (n=60, 66, 67, 55) -0.00  (0.019) 0.00  (0.025) -0.00  (0.017) -0.02  (0.013)
Change from BL at Week 76 (n=51, 58, 63, 49) -0.03  (0.014) -0.04  (0.022) -0.02  (0.013) -0.03  (0.020)
Change from BL at Week 89 (n=48, 58, 56, 42) -0.03  (0.019) -0.02  (0.025) -0.02  (0.013) -0.02  (0.020)
Change from BL at Week 102 (n=39, 47, 50, 40) 0.02  (0.025) 0.01  (0.027) 0.02  (0.016) -0.01  (0.018)
Change from BL at Week 115 (n=34, 43, 42, 34) -0.00  (0.019) 0.07  (0.051) -0.01  (0.019) -0.00  (0.023)
Change from BL at Week 128 (n=30, 40, 40, 29) -0.02  (0.017) 0.02  (0.046) -0.03  (0.014) -0.01  (0.025)
Change from BL at Week 141 (n=28, 38, 34, 28) -0.01  (0.020) -0.00  (0.019) -0.00  (0.016) 0.01  (0.020)
Change from BL at Week 154 (n=26, 33, 31, 24) 0.00  (0.017) -0.00  (0.019) -0.01  (0.018) 0.03  (0.021)
Change from BL at Week 167 (n=24, 33, 30, 25) -0.02  (0.014) -0.02  (0.020) 0.01  (0.017) 0.06  (0.039)
Change from BL at Week 180 (n=21, 28, 28, 26) -0.02  (0.013) -0.01  (0.021) -0.00  (0.014) 0.07  (0.040)
Change from BL at Week 193 (n=19, 25, 26, 23) -0.01  (0.019) -0.01  (0.024) 0.00  (0.017) 0.05  (0.032)
Change from BL at Week 206 (n=17, 22, 23, 21) 0.00  (0.026) -0.00  (0.028) 0.03  (0.016) 0.06  (0.026)
25.Other Pre-specified Outcome
Title Changes From Baseline in Systolic Blood Pressure During the ST + LT Period
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: mmHg
Change from BL at Week 2 (n=96, 100, 94, 89) -1.0  (1.4) -2.0  (1.3) -2.3  (1.2) -3.1  (1.4)
Change from BL at Week 4 (n=96, 100, 92, 91) -1.9  (1.4) -1.2  (1.1) -2.3  (1.1) -4.3  (1.4)
Change from BL at Week 6 (n=91, 98, 88, 84) -1.5  (1.4) -2.1  (1.2) -3.5  (1.3) -4.5  (1.4)
Change from BL at Week 8 (n=94, 91, 91, 80) -3.0  (1.4) -1.8  (1.2) -4.0  (1.2) -5.5  (1.5)
Change from BL at Week 10 (n=51, 66, 51, 50) -3.6  (2.0) -2.9  (1.5) -5.0  (1.5) -6.1  (1.7)
Change from BL at Week 12 (n=82, 83, 87, 79) -3.3  (1.3) -2.9  (1.2) -2.8  (1.3) -3.2  (1.6)
Change from BL at Week 14 (n=65, 72, 66, 62) -4.9  (1.6) -2.0  (1.5) -6.0  (1.7) -1.9  (1.6)
Change from BL at Week 16 (n=87, 87, 81, 72) -3.2  (1.4) -2.1  (1.3) -3.8  (1.4) -2.1  (1.5)
Change from BL at Week 18 (n=73, 69, 76, 66) -5.1  (1.7) -0.9  (1.5) -4.3  (1.7) -4.7  (1.9)
Change from BL at Week 20 (n=84, 80, 76, 73) -5.0  (1.6) -3.2  (1.3) -3.3  (1.4) -4.9  (1.7)
Change from BL at Week 22 (n=78, 73, 76, 64) -6.1  (1.7) -4.5  (1.3) -5.9  (1.5) -3.9  (1.9)
Change from BL at Week 24 (n=84, 83, 77, 75) -2.8  (1.5) -4.1  (1.2) -6.2  (1.5) -6.3  (1.7)
Change from BL at Week 30 (n=79, 78, 79, 66) -3.6  (1.7) -3.8  (1.5) -3.9  (1.5) -5.4  (1.9)
Change from BL at Week 37 (n=77, 74, 71, 66) -3.0  (1.7) -3.5  (1.4) -5.2  (1.5) -3.6  (1.7)
Change from BL at Week 50 (n=70, 73, 73, 62) -2.5  (1.7) 0.1  (1.4) -3.3  (1.5) -0.4  (1.9)
Change from BL at Week 63 (n=62, 66, 69, 56) -1.2  (1.9) -0.3  (1.4) -1.1  (1.5) -2.4  (2.1)
Change from BL at Week 76 (n=53, 59, 64, 50) -2.9  (1.7) -2.6  (1.6) -3.1  (1.8) -0.9  (2.2)
Change from BL at Week 89 (n=49, 58, 56, 44) -2.8  (2.0) -3.4  (1.4) -5.4  (2.0) -2.2  (2.2)
Change from BL at Week 102 (n=42, 47, 50, 40) -0.6  (2.1) -1.1  (1.9) -2.9  (2.1) -1.0  (2.5)
Change from BL at Week 115 (n=34, 43, 43, 37) -2.6  (2.4) -2.6  (2.0) -1.6  (1.9) 0.9  (2.7)
Change from BL at Week 128 (n=31, 40, 41, 31) -5.1  (2.5) -5.5  (1.9) 0.0  (1.9) 1.1  (2.7)
Change from BL at Week 141 (n=29, 40, 35, 29) -1.8  (3.0) -5.2  (2.3) 0.3  (2.6) -1.4  (3.1)
Change from BL at Week 154 (n=27, 36, 33, 27) -0.8  (2.8) -0.5  (2.3) 3.5  (2.6) 2.3  (3.1)
Change from BL at Week 167 (n=24, 33, 30, 27) 0.7  (2.9) -1.8  (2.5) 4.0  (2.5) -0.6  (3.1)
Change from BL at Week 180 (n=21, 28, 28, 27) 0.9  (2.9) -5.4  (3.2) 0.9  (2.4) -0.8  (2.6)
Change from BL at Week 193 (n=19, 26, 27, 24) 3.4  (4.0) -7.5  (3.2) 0.0  (3.0) -2.6  (3.6)
Change from BL at Week 206 (n=17, 24, 24, 23) 4.8  (5.0) -2.8  (3.3) 2.3  (2.6) 0.7  (4.0)
26.Other Pre-specified Outcome
Title Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: mmHg
Change from BL at Week 2 (n=96, 100, 94, 89) -0.0  (0.7) -1.2  (0.8) -0.5  (0.7) -1.5  (0.9)
Change from BL at Week 4 (n=96, 100, 92, 91) -1.4  (0.7) -1.1  (0.8) 0.3  (0.8) -1.8  (0.8)
Change from BL at Week 6 (n=91, 98, 88, 84) -1.5  (0.8) -0.9  (0.8) -0.8  (0.9) -1.9  (0.9)
Change from BL at Week 8 (n=94, 91, 91, 80) -1.4  (0.9) -0.9  (0.8) -0.7  (0.8) -2.4  (0.8)
Change from BL at Week 10 (n=51, 66, 51, 50) -0.8  (1.2) -1.1  (1.1) -1.3  (0.9) -3.4  (1.1)
Change from BL at Week 12 (n=82, 83, 87, 79) -1.3  (0.9) -2.0  (0.9) -0.7  (0.8) -1.8  (1.0)
Change from BL at Week 14 (n=65, 72, 66, 62) -2.5  (0.9) -2.4  (1.1) -2.4  (1.0) -2.7  (1.0)
Change from BL at Week 16 (n=87, 87, 81, 72) -1.5  (0.9) -0.5  (0.8) -0.1  (0.9) -2.1  (1.0)
Change from BL at Week 18 (n=73, 69, 76, 66) -2.3  (1.0) -1.6  (0.9) -1.9  (0.9) -2.1  (1.1)
Change from BL at Week 20 (n=84, 80, 76, 73) -2.2  (0.9) -1.8  (0.9) -1.9  (1.0) -2.2  (1.0)
Change from BL at Week 22 (n=78, 73, 76, 64) -3.0  (0.9) -2.0  (0.9) -2.5  (0.9) -1.7  (1.1)
Change from BL at Week 24 (n=84, 83, 77, 75) -1.5  (1.0) -1.7  (0.8) -2.3  (0.9) -3.4  (1.0)
Change from BL at Week 30 (n=79, 78, 79, 66) -1.4  (0.9) -2.2  (0.9) -0.3  (0.9) -2.8  (1.0)
Change from BL at Week 37 (n=77, 74, 71, 66) -0.4  (1.1) -1.7  (0.9) -0.6  (1.0) -2.0  (1.0)
Change from BL at Week 50 (n=70, 73, 73, 62) -1.7  (1.2) 0.3  (0.8) -0.3  (1.0) -0.6  (1.1)
Change from BL at Week 63 (n=61, 66, 69, 56) -0.1  (1.2) -0.4  (1.0) -0.0  (1.0) -0.5  (1.2)
Change from BL at Week 76 (n=53, 59, 64, 50) -1.6  (1.2) -2.0  (0.8) 0.1  (1.1) -0.3  (1.4)
Change from BL at Week 89 (n=49, 58, 56, 44) 0.4  (1.2) -2.1  (1.0) -1.6  (1.2) -0.1  (1.4)
Change from BL at Week 102 (n=42, 51, 51, 42) -1.1  (1.3) -2.0  (1.2) -0.4  (1.2) -1.2  (1.2)
Change from BL at Week 115 (n=34, 43, 43, 37) -0.9  (1.5) -2.7  (1.3) -1.1  (1.1) -1.0  (1.5)
Change from BL at Week 128 (n=31, 40, 41, 31) -1.8  (1.5) -3.7  (1.2) 1.1  (1.3) 1.0  (1.6)
Change from BL at Week 141 (n=29, 40, 35, 29) 0.9  (1.5) -2.0  (1.5) 1.1  (1.7) 1.3  (1.8)
Change from BL at Week 154 (n=27, 36, 33, 27) 1.2  (1.7) -0.8  (1.3) 2.5  (1.5) 1.3  (1.8)
Change from BL at Week 167 (n=24, 33, 30, 27) 0.8  (1.6) 0.3  (1.4) 2.4  (1.8) -1.1  (1.8)
Change from BL at Week 180 (n=21, 28, 28, 27) 1.4  (1.6) -2.0  (2.0) 0.5  (1.7) -0.8  (1.9)
Change from BL at Week 193 (n=19, 26, 27, 24) 0.8  (2.3) -1.6  (2.0) 0.5  (1.7) -0.2  (2.3)
Change from BL at Week 206 (n=17, 24, 24, 23) 0.3  (3.1) -0.6  (2.4) 1.9  (1.6) -0.2  (2.4)
27.Other Pre-specified Outcome
Title Changes From Baseline in Heart Rate During the ST + LT Period
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Mean (Standard Error)
Unit of Measure: beats per minute
Change from BL at Week 2 (n=96, 100, 94, 89) -0.1  (0.9) -0.5  (0.8) 0.2  (0.8) 0.3  (0.9)
Change from BL at Week 4 (n=96, 100, 92, 91) 0.2  (0.9) -1.1  (0.8) 0.7  (0.7) -0.1  (0.9)
Change from BL at Week 6 (n=91, 98, 88, 84) -1.5  (0.9) -0.6  (0.8) -0.6  (0.8) 1.4  (1.0)
Change from BL at Week 8 (n=94, 91, 91, 80) -0.5  (0.9) -0.9  (0.8) 0.2  (0.8) -0.2  (0.9)
Change from BL at Week 10 (n=51, 66, 51, 49) -0.2  (1.2) -1.5  (0.9) -1.0  (1.2) 0.1  (1.3)
Change from BL at Week 12 (n=82, 83, 87, 79) 0.3  (1.0) -1.2  (0.8) 0.5  (0.9) 0.8  (1.1)
Change from BL at Week 14 (n=65, 72, 65, 62) 0.1  (1.1) -0.5  (0.9) 0.6  (1.1) 1.9  (1.1)
Change from BL at Week 16 (n=87, 87, 81, 72) -0.8  (0.9) -1.5  (0.9) -0.1  (0.9) -0.1  (1.0)
Change from BL at Week 18 (n=73, 69, 76, 66) -0.0  (1.1) -0.8  (1.1) 1.5  (1.0) 2.6  (1.0)
Change from BL at Week 20 (n=84, 80, 76, 73) 1.3  (0.9) -1.5  (0.9) 1.3  (0.9) 0.8  (1.1)
Change from BL at Week 22 (n=78, 73, 76, 64) 0.1  (1.0) -0.3  (0.9) 0.9  (0.9) 1.5  (1.0)
Change from BL at Week 24 (n=84, 83, 77, 75) -0.3  (1.1) 0.1  (1.1) -0.7  (0.9) -0.4  (1.1)
Change from BL at Week 30 (n=79, 78, 79, 66) -0.1  (1.0) -1.2  (1.1) -0.7  (0.8) -1.2  (1.3)
Change from BL at Week 37 (n=77, 74, 71, 66) -0.4  (1.0) -1.4  (0.9) 0.5  (1.0) -0.9  (1.2)
Change from BL at Week 50 (n=70, 73, 73, 62) -0.1  (0.9) -0.7  (1.1) -0.2  (1.0) -0.2  (1.2)
Change from BL at Week 63 (n=62, 66, 69, 56) -0.4  (1.1) -2.5  (1.0) 0.9  (1.1) 0.6  (1.4)
Change from BL at Week 76 (n=53, 59, 64, 50) -0.3  (1.4) -3.3  (1.1) 0.4  (1.1) 0.2  (1.6)
Change from BL at Week 89 (n=49, 58, 56, 44) -0.5  (1.4) -1.5  (1.2) -0.9  (1.1) -0.3  (1.3)
Change from BL at Week 102 (n=42, 51, 51, 42) -2.8  (1.4) -1.5  (1.4) -0.1  (1.4) -0.0  (1.6)
Change from BL at Week 115 (n=34, 43, 43, 37) -3.2  (1.7) -2.3  (1.3) 1.0  (1.6) 0.8  (1.9)
Change from BL at Week 128 (n=31, 40, 41, 31) -2.1  (1.8) -4.5  (1.6) -0.7  (1.4) 1.7  (1.8)
Change from BL at Week 141 (n=29, 40, 35, 29) -2.8  (1.4) -3.5  (1.5) -0.6  (1.6) 0.9  (1.7)
Change from BL at Week 154 (n=27, 36, 33, 27) -2.0  (2.1) -2.6  (1.6) -1.3  (1.8) -0.6  (2.0)
Change from BL at Week 167 (n=24, 33, 30, 27) -5.1  (1.9) -0.8  (1.4) -2.1  (2.4) 0.5  (1.6)
Change from BL at Week 180 (n=21, 28, 28, 27) -3.1  (2.1) -5.3  (1.8) -2.0  (2.0) -1.2  (1.4)
Change from BL at Week 193 (n=19, 26, 27, 24) -4.6  (2.4) -4.2  (1.8) -2.4  (2.0) 1.1  (2.1)
Change from BL at Week 206 (n=17, 24, 24, 23) -5.3  (2.6) -2.6  (1.9) 0.0  (2.7) -0.8  (2.1)
28.Other Pre-specified Outcome
Title Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period
Hide Description The normality/abnormality of the ECG tracing was determined by the investigator.
Time Frame Baseline, Weeks 12, 24, 76, 102, 154, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; BL n=number of participants at baseline
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Measure Type: Number
Unit of Measure: participants
Normal BL, Normal Week 12 (BL n=65, 66, 67, 47) 57 56 59 43
Normal BL, Abnormal Week 12 (BL n=65, 66, 67, 47) 8 10 8 4
Abnormal BL, Normal Week 12 (BL n=27, 32, 26, 43) 6 6 9 15
Abnormal BL, Abnormal Week 12(BL n=27, 32, 26, 43) 21 26 17 28
Normal BL, Normal Week 24 (BL n=53, 52, 47, 33) 43 44 43 31
Normal BL, Abnormal Week 24 (BL n=53, 52, 47, 33) 10 8 4 2
Abnormal BL, Normal Week 24 (BL n=19, 24, 21, 25) 5 8 9 8
Abnormal BL, Abnormal Week 24(BL n=19, 24, 21, 25) 14 16 12 17
Normal BL, Normal Week 76 (BL n=48, 49, 48, 36) 37 44 40 30
Normal BL, Abnormal Week 76 (BL n=48, 49, 48, 36) 11 5 8 6
Abnormal BL, Normal Week 76 (BL n=19, 23, 21, 27) 8 8 6 13
Abnormal BL, Abnormal Week 76(BL n=19, 23, 21, 27) 11 15 15 14
Normal BL, Normal Week 102 (BL n=32, 32, 36, 22) 25 26 31 18
Normal BL, Abnormal Week 102 (BL n=32, 32, 36, 22) 7 6 5 4
Abnormal BL, Normal Week 102 (BL n=12, 18, 17, 20) 4 5 12 11
Abnormal BL,Abnormal Week 102(BL n=12, 18, 17, 20) 8 13 5 9
Normal BL, Normal Week 154 (BL n=20, 21, 26, 15) 16 17 23 14
Normal BL, Abnormal Week 154 (BL n=20, 21, 26, 15) 4 4 3 1
Abnormal BL, Normal Week 154 (BL n=7, 16, 11, 13) 4 4 5 7
Abnormal BL, Abnormal Week 154(BL n=7, 16, 11, 13) 3 12 6 6
Normal BL, Normal Week 206 (BL n=15, 13, 20, 14) 15 12 18 11
Normal BL, Abnormal Week 206 (BL n=15, 13, 20, 14) 0 1 2 3
Abnormal BL, Normal Week 206 (BL n=4, 13, 8, 11) 2 3 4 4
Abnormal BL, Abnormal Week 206 (BL n=4, 13, 8, 11) 2 10 4 7
29.Other Pre-specified Outcome
Title Overall Summary of Adverse Events During ST+LT Treatment Period - Open-Label Cohort
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.
Time Frame AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: participants
At Least 1 AE 49
At Least 1 Related AE 9
Deaths 0
At Least 1 SAE 6
At Least 1 Related SAE 0
Discontinuations Due to SAEs 2
Discontinuations Due to AEs 5
30.Other Pre-specified Outcome
Title Marked Laboratory Abnormalities During ST + LT Treatment Period - Open-Label Cohort
Hide Description A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; unspec=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.
Time Frame Lab assessments taken during and up to 14 days after the last dose of study drug during the ST + LT Treatment Period. Mean duration of exposure was 34 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: participants
Hemoglobin < 8 g/dL (n=64) 0
Hematocrit < 0.75 x pre-Rx (n=64) 0
Platelets < 50 x 10^9 c/L (n=64) 0
Platelets > 1.5 x ULN (n=64) 0
Leukocytes < 2 x 1000 c/µL (n=64) 0
Neutrophils+Bands <1x1000 c/uL (n=64) 1
Eosinophils >0.9x1000 c/µL (n=64) 2
Lymphocytes <=0.75x1000 c/uL (n=64) 0
ALP >3 x pre-Rx and >ULN (n=64) 0
ALP >1.5 x ULN (n=64) 0
AST >3 x ULN (n=64) 1
AST >5 x ULN (n=64) 0
AST >10 x ULN (n=64) 0
AST >20 x ULN (n=64) 0
ALT >3 x ULN (n=64) 1
ALT >5 x ULN (n=64) 0
ALT >10 x ULN (n=64) 0
ALT >20 x ULN (n=64) 0
Bilirubin Total >2mg/dL (n=64) 1
Bilirubin Total >1.5xULN (n=64) 1
Bilirubin Total >2xULN (n=64) 0
BUN >2 x pre-Rx and >ULN (n=64) 2
Creatinine >2.5 mg/dL (n=64) 0
Glucose, Serum Fasting < 50 mg/dL (n=1) 0
Glucose, Serum Fasting > 500 mg/dL (n=1) 0
Glucose, Serum Unspec. < 50 mg/dL (n=1) 0
Glucose, Serum Unspec. > 500 mg/dL (n=1) 0
Glucose, Plasma Fasting <50 mg/dL (n=64) 0
Glucose,Plasma Fasting >500 mg/dL (n=64) 0
Glucose, Plasma Unspec. <50 mg/dL (n=65) 2
Glucose,Plasma Unspec. >500 mg/dL (n=65) 1
Sodium,Serum Low (see above) (n=65) 0
Sodium,Serum High (see above) (n=65) 2
Potassium,Serum Low (see above) (n=65) 0
Potassium, Serum High (see above) (n=65) 2
Chloride < 90 mEq/L (n=65) 1
Chloride > 120 mEq/L (n=65) 0
Albumin < 0.9 LLN (n=64) 0
Creatine Kinase > 5 x ULN (n=64) 0
Uric Acid > 1.5 x ULN (n=0) 0
Protein Urine, >=2-4 (n=64) 2
Blood Urine, >=2-4 (n=64) 4
Red Blood Cells Urine >=2-4 (n=58) 7
White Blood Cells Urine >=2-4 (n=58) 6
31.Other Pre-specified Outcome
Title All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period
Hide Description Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.
Time Frame AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Measure Type: Number
Unit of Measure: participants
9 11 10 9
32.Other Pre-specified Outcome
Title Confirmed Hypoglycemia During ST + LT Treatment Period
Hide Description 'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms
Time Frame AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 109 weeks in 10 mg arm, 94.7 weeks in 2.5 mg arm, 103 weeks in 5 mg arm, and 98.4 weeks in placebo arm.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Saxagliptin 2.5 mg Saxagliptin 5 mg Saxagliptin 10 mg Placebo
Hide Arm/Group Description:
Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
Overall Number of Participants Analyzed 102 106 98 95
Measure Type: Number
Unit of Measure: participants
1 1 0 0
33.Other Pre-specified Outcome
Title All Reported Hypoglycemic Adverse Events During ST + LT Treatment Period - Open-Label Cohort
Hide Description Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.
Time Frame AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: participants
2
34.Other Pre-specified Outcome
Title Confirmed Hypoglycemia During ST + LT Treatment Period - Open-Label Cohort
Hide Description 'Confirmed' = recorded on the hypoglycemia AE case report form page with a fingerstick glucose <= 50 mg/dL and associated symptoms
Time Frame AEs: up to last treatment day + 1 day or last visit; SAEs: up to last treatment day + 30 days or last visit + 30 days. Mean duration of exposure was 34 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: participants
0
35.Other Pre-specified Outcome
Title Electrocardiogram (ECG) Tracings - Shift Table From Baseline (BL) to Selected Visits During ST + LT Treatment Period - Open Label Cohort
Hide Description The normality/abnormality of the ECG tracing was determined by the investigator.
Time Frame Baseline, Weeks 12, 24, 76, 102, 154, 206
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; BL n=number of participants at baseline
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Measure Type: Number
Unit of Measure: participants
Normal BL, Normal Week 12 (BL n=23) 19
Normal BL, Abnormal Week 12 (BL n=23) 4
Abnormal BL, Normal Week 12 (BL n=18) 5
Abnormal BL, Abnormal Week 12 (BL n=18) 13
Normal BL, Normal Week 24 (BL n=10) 8
Normal BL, Abnormal Week 24 (BL n=10) 2
Abnormal BL, Normal Week 24 (BL n=6) 2
Abnormal BL, Abnormal Week 24(BL n=6) 4
Normal BL, Normal Week 76 (BL n=17) 13
Normal BL, Abnormal Week 76 (BL n=17) 4
Abnormal BL, Normal Week 76 (BL n=13) 4
Abnormal BL, Abnormal Week 76 (BL n=13) 9
Normal BL, Normal Week 102 (BL n=8) 6
Normal BL, Abnormal Week 102 (BL n=8) 2
Abnormal BL, Normal Week 102 (BL n=4) 1
Abnormal BL, Abnormal Week 102 (BL n=4) 3
Normal BL, Normal Week 154 (BL n=4) 3
Normal BL, Abnormal Week 154 (BL n=4) 1
Abnormal BL, Normal Week 154 (BL n=2) 0
Abnormal BL, Abnormal Week 154 (BL n=2) 2
Normal BL, Normal Week 206 (BL n=3) 2
Normal BL, Abnormal Week 206 (BL n=3) 1
Abnormal BL, Normal Week 206 (BL n=1) 0
Abnormal BL, Abnormal Week 206 (BL n=1) 1
36.Other Pre-specified Outcome
Title Changes From Baseline in Systolic Blood Pressure During the ST + LT Period - Open Label Cohort
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Mean (Standard Error)
Unit of Measure: mmHg
Change from BL at Week 2 (n=62) -4.4  (1.3)
Change from BL at Week 4 (n=59) -3.8  (1.4)
Change from BL at Week 6 (n=60) -2.7  (1.5)
Change from BL at Week 8 (n=49) -5.1  (1.6)
Change from BL at Week 10 (n=24) -4.2  (2.8)
Change from BL at Week 12 (n=47) -4.9  (1.8)
Change from BL at Week 14 (n=35) -5.1  (2.0)
Change from BL at Week 16 (n=46) -1.9  (2.2)
Change from BL at Week 18 (n=42) -5.8  (2.0)
Change from BL at Week 20 (n=45) -3.6  (2.0)
Change from BL at Week 22 (n=44) -4.0  (2.1)
Change from BL at Week 24 (n=44) -4.3  (2.1)
Change from BL at Week 30 (n=40) -4.8  (1.8)
Change from BL at Week 37 (n=35) -4.7  (1.8)
Change from BL at Week 50 (n=36) -1.6  (2.1)
Change from BL at Week 63 (n=26) -0.7  (2.7)
Change from BL at Week 76 (n=24) -1.9  (2.1)
Change from BL at Week 89 (n=23) -4.0  (2.6)
Change from BL at Week 102 (n=15) 0.9  (2.4)
Change from BL at Week 115 (n=13) -6.6  (3.6)
Change from BL at Week 128 (n=11) -5.6  (4.3)
Change from BL at Week 141 (n=10) -7.2  (4.4)
Change from BL at Week 154 (n=10) 5.7  (4.7)
Change from BL at Week 167 (n=10) -2.2  (4.4)
37.Other Pre-specified Outcome
Title Changes From Baseline in Diastolic Blood Pressure During the ST + LT Period - Open Label Cohort
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Mean (Standard Error)
Unit of Measure: mmHg
Change from BL at Week 2 (n=62) -3.7  (0.9)
Change from BL at Week 4 (n=59) -1.7  (1.0)
Change from BL at Week 6 (n=60) -2.8  (1.0)
Change from BL at Week 8 (n=49) -2.0  (1.1)
Change from BL at Week 10 (n=24) -1.0  (2.0)
Change from BL at Week 12 (n=47) -3.7  (1.4)
Change from BL at Week 14 (n=35) -4.5  (1.7)
Change from BL at Week 16 (n=46) -2.8  (1.2)
Change from BL at Week 18 (n=42) -3.3  (1.1)
Change from BL at Week 20 (n=45) -2.1  (1.2)
Change from BL at Week 22 (n=44) -2.8  (1.5)
Change from BL at Week 24 (n=44) -3.4  (1.3)
Change from BL at Week 30 (n=40) -3.8  (1.5)
Change from BL at Week 37 (n=35) -2.0  (1.4)
Change from BL at Week 50 (n=36) -1.3  (1.4)
Change from BL at Week 63 (n=26) -0.9  (1.8)
Change from BL at Week 76 (n=24) -1.0  (2.0)
Change from BL at Week 89 (n=23) -2.6  (1.9)
Change from BL at Week 102 (n=15) 1.0  (3.0)
Change from BL at Week 115 (n=13) -4.1  (2.5)
Change from BL at Week 128 (n=11) -3.7  (2.8)
Change from BL at Week 141 (n=10) -6.0  (2.6)
Change from BL at Week 154 (n=10) -0.5  (2.7)
Change from BL at Week 167 (n=10) -2.5  (2.9)
38.Other Pre-specified Outcome
Title Changes From Baseline in Heart Rate During the ST + LT Period - Open Label Cohort
Hide Description [Not Specified]
Time Frame Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 30, 37, 50, 63, 76, 89, 102, 115, 128, 141, 154, 167
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants; n=number of treated participants with measurement at time point
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees)
Hide Arm/Group Description:
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
Overall Number of Participants Analyzed 66
Mean (Standard Error)
Unit of Measure: beats per minute
Change from BL at Week 2 (n=62) -0.8  (1.0)
Change from BL at Week 4 (n=59) -0.4  (1.1)
Change from BL at Week 6 (n=60) -0.3  (1.0)
Change from BL at Week 8 (n=49) -0.7  (1.5)
Change from BL at Week 10 (n=23) -1.8  (2.1)
Change from BL at Week 12 (n=47) -3.0  (1.1)
Change from BL at Week 14 (n=34) -2.0  (1.4)
Change from BL at Week 16 (n=46) -0.7  (1.1)
Change from BL at Week 18 (n=42) -2.0  (1.3)
Change from BL at Week 20 (n=45) 1.6  (1.1)
Change from BL at Week 22 (n=43) -0.4  (1.2)
Change from BL at Week 24 (n=44) -0.4  (1.5)
Change from BL at Week 30 (n=40) 0.6  (1.3)
Change from BL at Week 37 (n=35) -1.6  (1.6)
Change from BL at Week 50 (n=36) -2.9  (1.3)
Change from BL at Week 63 (n=26) -3.0  (1.6)
Change from BL at Week 76 (n=24) -0.4  (2.5)
Change from BL at Week 89 (n=23) -1.3  (1.8)
Change from BL at Week 102 (n=15) -0.3  (1.6)
Change from BL at Week 115 (n=13) 1.7  (1.6)
Change from BL at Week 128 (n=11) -1.6  (3.6)
Change from BL at Week 141 (n=10) -3.4  (1.7)
Change from BL at Week 154 (n=10) -1.5  (2.6)
Change from BL at Week 167 (n=10) -1.9  (3.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-Label Treatment Cohort (Direct Enrollees) Placebo Saxagliptin 10 mg Saxagliptin 2.5 mg Saxagliptin 5 mg
Hide Arm/Group Description Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue) Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue). Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
All-Cause Mortality
Open-Label Treatment Cohort (Direct Enrollees) Placebo Saxagliptin 10 mg Saxagliptin 2.5 mg Saxagliptin 5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Open-Label Treatment Cohort (Direct Enrollees) Placebo Saxagliptin 10 mg Saxagliptin 2.5 mg Saxagliptin 5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/66 (9.09%)   11/95 (11.58%)   9/98 (9.18%)   11/102 (10.78%)   18/106 (16.98%) 
Cardiac disorders           
TACHYCARDIA † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
ANGINA UNSTABLE † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
ATRIAL FIBRILLATION † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  2/106 (1.89%) 
AORTIC VALVE STENOSIS † 1  0/66 (0.00%)  0/95 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  0/106 (0.00%) 
MYOCARDIAL INFARCTION † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
CORONARY ARTERY DISEASE † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  2/102 (1.96%)  1/106 (0.94%) 
CARDIAC FAILURE CONGESTIVE † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
ACUTE MYOCARDIAL INFARCTION † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
SUPRAVENTRICULAR TACHYCARDIA † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
Endocrine disorders           
ADRENAL MASS † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
Gastrointestinal disorders           
ABDOMINAL PAIN † 1  0/66 (0.00%)  0/95 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  0/106 (0.00%) 
INTESTINAL MASS † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
ABDOMINAL PAIN UPPER † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
ABDOMINAL TENDERNESS † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
SMALL INTESTINAL OBSTRUCTION † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
General disorders           
CHEST PAIN † 1  0/66 (0.00%)  1/95 (1.05%)  1/98 (1.02%)  1/102 (0.98%)  0/106 (0.00%) 
NON-CARDIAC CHEST PAIN † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
Hepatobiliary disorders           
CHOLELITHIASIS † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
GALLBLADDER POLYP † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
CHOLECYSTITIS ACUTE † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
Infections and infestations           
GANGRENE † 1  1/66 (1.52%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
PNEUMONIA † 1  1/66 (1.52%)  1/95 (1.05%)  0/98 (0.00%)  2/102 (1.96%)  0/106 (0.00%) 
CELLULITIS † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  2/106 (1.89%) 
HEPATITIS C † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
APPENDICITIS † 1  0/66 (0.00%)  0/95 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  0/106 (0.00%) 
TUBERCULOSIS † 1  0/66 (0.00%)  0/95 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  0/106 (0.00%) 
PYELONEPHRITIS † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
GASTROENTERITIS † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
HAEMATOMA INFECTION † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
Injury, poisoning and procedural complications           
WOUND † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
MULTIPLE FRACTURES † 1  1/66 (1.52%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
Metabolism and nutrition disorders           
DEHYDRATION † 1  1/66 (1.52%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
Musculoskeletal and connective tissue disorders           
BACK PAIN † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
OSTEOARTHRITIS † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  2/106 (1.89%) 
MUSCULOSKELETAL PAIN † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
COLON CANCER † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/106 (0.94%) 
BRAIN NEOPLASM † 1  0/66 (0.00%)  0/95 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  0/106 (0.00%) 
PROSTATE CANCER † 1  1/66 (1.52%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
CERVIX CARCINOMA † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
MALIGNANT MELANOMA † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
BASAL CELL CARCINOMA † 1  0/66 (0.00%)  0/95 (0.00%)  1/98 (1.02%)  1/102 (0.98%)  0/106 (0.00%) 
RENAL CELL CARCINOMA † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
LUNG NEOPLASM MALIGNANT † 1  0/66 (0.00%)  0/95 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  0/106 (0.00%) 
SQUAMOUS CELL CARCINOMA † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  0/106 (0.00%) 
SQUAMOUS CELL CARCINOMA OF SKIN † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
Nervous system disorders           
SYNCOPE † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  2/102 (1.96%)  1/106 (0.94%) 
SCIATICA † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
VASCULAR HEADACHE † 1  0/66 (0.00%)  1/95 (1.05%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
IVTH NERVE PARALYSIS † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
CEREBROVASCULAR ACCIDENT † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  2/106 (1.89%) 
Pregnancy, puerperium and perinatal conditions           
ABORTION SPONTANEOUS † 1  0/66 (0.00%)  0/95 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  1/106 (0.94%) 
Renal and urinary disorders           
NEPHROLITHIASIS † 1  1/66 (1.52%)  1/95 (1.05%)  0/98 (0.00%)  0/102 (0.00%)  0/106 (0.00%) 
Reproductive system and breast disorders