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A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

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ClinicalTrials.gov Identifier: NCT00870194
Recruitment Status : Completed
First Posted : March 27, 2009
Results First Posted : June 17, 2011
Last Update Posted : April 9, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
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 Type 2 Diabetes Mellitus
Interventions Drug: exenatide and sitagliptin
Drug: exenatide and placebo
Enrollment 255

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day. Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Period Title: Overall Study
Started 127 128
Per Protocol Set 97 111
Completed 101 114
Not Completed 26 14
Reason Not Completed
Adverse Event             10             5
Lack of Efficacy             0             1
Lost to Follow-up             2             0
Physician Decision             3             1
Protocol Violation             3             3
Entry Criteria Not Met             1             2
Subject Decision             7             2
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin Total
Hide Arm/Group Description Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day. Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day. Total of all reporting groups
Overall Number of Baseline Participants 97 111 208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 111 participants 208 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
81
  83.5%
97
  87.4%
178
  85.6%
>=65 years
16
  16.5%
14
  12.6%
30
  14.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 111 participants 208 participants
54.8  (10.97) 54.6  (9.66) 54.7  (10.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 111 participants 208 participants
Female
46
  47.4%
58
  52.3%
104
  50.0%
Male
51
  52.6%
53
  47.7%
104
  50.0%
1.Primary Outcome
Title Change in HbA1c (Percent)
Hide Description Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values [X% - Y%]
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 97 111
Least Squares Mean (Standard Error)
Unit of Measure: Percent HbA1c
-0.38  (0.09) -0.68  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-Inferiority Margin of 0.4%
Statistical Test of Hypothesis P-Value .012
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments Power calculation: 80% assuming 200 patients (100 in each arm), no true difference and 1.0% standard deviation.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin of 0.4%
Statistical Test of Hypothesis P-Value .012
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
0.07 to 0.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.12
Estimation Comments Standard Error of the Least Square Mean
2.Secondary Outcome
Title Percentage of Patients Achieving HbA1c <=7.0%
Hide Description Percentage of patients whose baseline HbA1c was > 7.0% achieving HbA1c <=7.0% at endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients in the Per Protocol Set whose baseline HbA1c was > 7.0%; Last Observation Carried Forward.Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 88 106
Measure Type: Number
Unit of Measure: Percentage
29.5 44.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .038
Comments [Not Specified]
Method Fisher`s Exact Test
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients Achieving HbA1c <7.0%
Hide Description Percentage of patients whose baseline HbA1c was >=7.0% achieving HbA1c <7.0% at endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients in the Per Protocol Set whose baseline HbA1c was >= 7.0%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 94 108
Measure Type: Number
Unit of Measure: Percentage
26.6 41.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .027
Comments [Not Specified]
Method Fisher`s Exact Test
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Patients Achieving HbA1c <=6.5%
Hide Description Percentage of patients whose baseline HbA1c was > 6.5% achieving HbA1c <=6.5% at endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients in the Per Protocol Set whose baseline HbA1c was > 6.5%; Last Observation Carried Forward. Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 97 111
Measure Type: Number
Unit of Measure: Percentage
16.5 20.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .480
Comments [Not Specified]
Method Fisher`s Exact Test
Comments [Not Specified]
5.Secondary Outcome
Title Change in FSG (mmol/L)
Hide Description Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 93 106
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.06  (0.23) -0.55  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .038
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change in Body Weight (kg)
Hide Description Change in body weight from baseline to endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 97 111
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.58  (0.25) -2.20  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .266
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
7.Secondary Outcome
Title Change in Waist Circumference (cm)
Hide Description Change in waist circumference from baseline to endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 96 111
Least Squares Mean (Standard Error)
Unit of Measure: cm
-3.25  (0.40) -2.36  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .095
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
8.Secondary Outcome
Title Waist-to-Hip Ratio
Hide Description Change in waist-to-hip ratio from baseline to endpoint (Week20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 96 111
Least Squares Mean (Standard Error)
Unit of Measure: Ratio
-0.01  (0.00) -0.00  (0.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .567
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
9.Secondary Outcome
Title SMBG (mmol/L)
Hide Description 7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 50 71
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
8.57  (0.26) 8.16  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .207
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
10.Secondary Outcome
Title Change in Triglycerides (mmol/L)
Hide Description Change in triglycerides from baseline to endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 96 109
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.17  (0.10) -0.07  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .055
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Change in HDL (mmol/L)
Hide Description Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 96 109
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.03  (0.02) -0.01  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .269
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Change in LDL (mmol/L)
Hide Description Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 90 98
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.06  (0.06) 0.10  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .622
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Change in Total Cholesterol (mmol/L)
Hide Description Change in total cholesterol from baseline to endpoint (Week 20)
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set: the set of data generated by the subset of patients who sufficiently complied with the protocol to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 96 109
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.09  (0.07) 0.08  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .888
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Incidence of Hypoglycemia (Overall)
Hide Description Incidence of hypoglycemic episodes experienced overall during the study
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; not confirmed with blood glucose values.
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 127 128
Measure Type: Number
Unit of Measure: Participants
5 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .287
Comments [Not Specified]
Method Fisher`s Exact Test
Comments [Not Specified]
15.Secondary Outcome
Title Incidence of Severe Hypoglycemia(Overall)
Hide Description Incidence of severe hypoglycemia experienced overall during the study
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As Treated Patients; Severe hypo:symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose;or documented hypoglycemia (BG< 3.0 mmol/L [54/mg/dL]) requiring the assistance of another person because of severe impairment in consciousness or behavior
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 127 128
Measure Type: Number
Unit of Measure: Participants
1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .498
Comments [Not Specified]
Method Fisher`s Exact Test
Comments [Not Specified]
16.Secondary Outcome
Title Incidence of Nocturnal Hypoglycemia (Overall)
Hide Description Incidence of nocturnal hypoglycemia experienced overall during the study
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As Treated Patients
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 127 128
Measure Type: Number
Unit of Measure: Participants
0 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .247
Comments [Not Specified]
Method Fisher`s Exact Test
Comments [Not Specified]
17.Secondary Outcome
Title Incidence of Confirmed Hypoglycemia(Overall)
Hide Description Incidence of confirmed hypoglycemia experienced overall during the study
Time Frame Baseline to 20 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As Treated Patients; Hypoglycemia defined as: patient experiencing a sign or symptom associated with hypoglycemia that is either self-treated or resolves on its own; has a concurrent fingerstick blood glucose <3.0 mmol/L (54 mg/dL).
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description:
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
Overall Number of Participants Analyzed 127 128
Measure Type: Number
Unit of Measure: Participants
1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide + Placebo, Exenatide + Sitagliptin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher`s Exact Test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide + Placebo Exenatide + Sitagliptin
Hide Arm/Group Description Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day. Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
All-Cause Mortality
Exenatide + Placebo Exenatide + Sitagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide + Placebo Exenatide + Sitagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   4/127 (3.15%)   6/128 (4.69%) 
Cardiac disorders     
Angina unstable * 1  0/127 (0.00%)  1/128 (0.78%) 
Coronary artery disease * 1  0/127 (0.00%)  1/128 (0.78%) 
Gastrointestinal disorders     
Lumbar hernia * 1  1/127 (0.79%)  0/128 (0.00%) 
Infections and infestations     
Urosepsis * 1  0/127 (0.00%)  1/128 (0.78%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  1/127 (0.79%)  1/128 (0.78%) 
Hyperglycaemia * 1  0/127 (0.00%)  1/128 (0.78%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/127 (0.79%)  0/128 (0.00%) 
Back pain * 1  1/127 (0.79%)  0/128 (0.00%) 
Lumbar spinal stenosis * 1  1/127 (0.79%)  0/128 (0.00%) 
Rotator cuff syndrome * 1  0/127 (0.00%)  1/128 (0.78%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer * 1  0/127 (0.00%)  1/128 (0.78%) 
Pancreatic carcinoma * 1  0/127 (0.00%)  1/128 (0.78%) 
Nervous system disorders     
Presyncope * 1  0/127 (0.00%)  1/128 (0.78%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/127 (0.00%)  1/128 (0.78%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  1/127 (0.79%)  0/128 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide + Placebo Exenatide + Sitagliptin
Affected / at Risk (%) Affected / at Risk (%)
Total   36/127 (28.35%)   28/128 (21.88%) 
Gastrointestinal disorders     
Nausea * 1  20/127 (15.75%)  13/128 (10.16%) 
Vomiting * 1  13/127 (10.24%)  4/128 (3.13%) 
Infections and infestations     
Nasopharyngitis * 1  11/127 (8.66%)  10/128 (7.81%) 
Nervous system disorders     
Headache * 1  6/127 (4.72%)  9/128 (7.03%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Peter Ohman, Medical Science Director
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00870194     History of Changes
Other Study ID Numbers: H8O-CR-GWDK
First Submitted: March 25, 2009
First Posted: March 27, 2009
Results First Submitted: April 11, 2011
Results First Posted: June 17, 2011
Last Update Posted: April 9, 2015