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Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin

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ClinicalTrials.gov Identifier: NCT02429258
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : April 11, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Type II Diabetes
Interventions Drug: Farxiga
Drug: Placebo
Drug: Metformin
Drug: Insulin
Enrollment 226
Recruitment Details  
Pre-assignment Details 226 subjects signed the informed consent form (ICF), and 132 subjects were screened to randomize a total of 100 subjects.
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description Dapagliflozin + Metformin or Insulin Placebo + Metformin or Insulin
Period Title: Overall Study
Started 50 50
Completed 48 49
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             0
Protocol Violation             0             1
Arm/Group Title Dapagliflozin Placebo Total
Hide Arm/Group Description Dapagliflozin + Metformin or Insulin Placebo + Metformin or Insulin Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
100 subjects were included in the safety and ITT population. 99 subjects were included in the evaluable population. 1 subject did not meet the I/E criteria.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
56.9  (7.11) 56.8  (9.71) 56.9  (8.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
24
  48.0%
25
  50.0%
49
  49.0%
Male
26
  52.0%
25
  50.0%
51
  51.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Black or African American 11 14 25
White 39 36 75
American Indian and Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
More than one race 0 0 0
Other 0 0 0
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 50 participants 50 participants 100 participants
34.3  (5.92) 33.2  (5.59) 33.8  (5.75)
Hemoglobin A1c (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 50 participants 50 participants 100 participants
8.31  (0.785) 8.37  (0.810) 8.34  (0.794)
1.Primary Outcome
Title Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-18.2  (4.33) 5.8  (4.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.0
Confidence Interval 95%
-36.1 to -12.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.08
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-10.0  (4.14) 5.3  (4.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.3
Confidence Interval 95%
-26.8 to -3.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.80
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: Change in percentage
0.3  (0.30) -0.6  (0.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.0
Confidence Interval 95%
0.1 to 1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.42
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: Change in percentage
12.2  (2.60) -2.8  (2.55)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.0
Confidence Interval 95%
7.7 to 22.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.65
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: Change in percentage
-12.6  (2.65) 3.5  (2.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.1
Confidence Interval 95%
-23.5 to -8.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.72
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-26.2  (5.99) 3.6  (5.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.7
Confidence Interval 95%
-46.6 to -12.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.47
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-50.9  (6.54) -10.0  (6.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -40.8
Confidence Interval 95%
-59.0 to -22.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.14
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in HbA1c From Baseline to Week 4
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: % Alc
-0.51  (0.07) -0.28  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval 95%
-0.43 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Fructosamine From Baseline to Week 4
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-20.4  (3.22) -9.6  (3.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.8
Confidence Interval 95%
-19.9 to -1.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.55
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-49.5  (6.61) -13.2  (6.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -36.3
Confidence Interval 95%
-54.7 to -17.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.25
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population
Hide Description [Not Specified]
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description:
Dapagliflozin + Metformin or Insulin
Placebo + Metformin or Insulin
Overall Number of Participants Analyzed 50 50
Least Squares Mean (Standard Error)
Unit of Measure: 10^-9 min^-1
8.4  (2.07) 1.4  (1.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dapagliflozin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.0
Confidence Interval 95%
1.3 to 12.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.86
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dapagliflozin Placebo
Hide Arm/Group Description Dapagliflozin + Metformin or Insulin Placebo + Metformin or Insulin
All-Cause Mortality
Dapagliflozin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Dapagliflozin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.05%
Dapagliflozin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/50 (6.00%)      3/50 (6.00%)    
Infections and infestations     
Urinary Tract Infection *  3/50 (6.00%)  3 3/50 (6.00%)  3
*
Indicates events were collected by non-systematic assessment
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.
Institution & PI agree they will not use or disclose and confidential information to third parties for a period of 10 years from receipt
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sergey Zhuplatov MD, PhD
Organization: AstraZeneca, PLL
Phone: 215-542-3222
EMail: sergey.zhuplatov@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02429258    
Other Study ID Numbers: D1690L00026
First Submitted: April 8, 2015
First Posted: April 29, 2015
Results First Submitted: October 7, 2016
Results First Posted: April 11, 2017
Last Update Posted: June 14, 2017