Trial Outcomes & Findings for Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin (NCT NCT02429258)
NCT ID: NCT02429258
Last Updated: 2017-06-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
226 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2017-06-14
Participant Flow
226 subjects signed the informed consent form (ICF), and 132 subjects were screened to randomize a total of 100 subjects.
Participant milestones
| Measure |
Dapagliflozin
Dapagliflozin + Metformin or Insulin
|
Placebo
Placebo + Metformin or Insulin
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Dapagliflozin
Dapagliflozin + Metformin or Insulin
|
Placebo
Placebo + Metformin or Insulin
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.9 Years
STANDARD_DEVIATION 7.11 • n=5 Participants
|
56.8 Years
STANDARD_DEVIATION 9.71 • n=7 Participants
|
56.9 Years
STANDARD_DEVIATION 8.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian and Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
34.3 kg/m^2
STANDARD_DEVIATION 5.92 • n=5 Participants
|
33.2 kg/m^2
STANDARD_DEVIATION 5.59 • n=7 Participants
|
33.8 kg/m^2
STANDARD_DEVIATION 5.75 • n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.31 Percentage
STANDARD_DEVIATION 0.785 • n=5 Participants
|
8.37 Percentage
STANDARD_DEVIATION 0.810 • n=7 Participants
|
8.34 Percentage
STANDARD_DEVIATION 0.794 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System
|
-18.2 mg/dL
Standard Error 4.33
|
5.8 mg/dL
Standard Error 4.25
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4
|
-10.0 mg/dL
Standard Error 4.14
|
5.3 mg/dL
Standard Error 4.06
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population
|
0.3 Change in percentage
Standard Error 0.30
|
-0.6 Change in percentage
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
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
|
12.2 Change in percentage
Standard Error 2.60
|
-2.8 Change in percentage
Standard Error 2.55
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population
|
-12.6 Change in percentage
Standard Error 2.65
|
3.5 Change in percentage
Standard Error 2.60
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4
|
-26.2 mg/dL
Standard Error 5.99
|
3.6 mg/dL
Standard Error 5.98
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4
|
-50.9 mg/dL
Standard Error 6.54
|
-10.0 mg/dL
Standard Error 6.39
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 4
|
-0.51 % Alc
Standard Error 0.07
|
-0.28 % Alc
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in Fructosamine From Baseline to Week 4
|
-20.4 mmol/L
Standard Error 3.22
|
-9.6 mmol/L
Standard Error 3.17
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4
|
-49.5 mg/dL
Standard Error 6.61
|
-13.2 mg/dL
Standard Error 6.46
|
SECONDARY outcome
Timeframe: Baseline to Week 4Outcome measures
| Measure |
Dapagliflozin
n=50 Participants
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 Participants
Placebo + Metformin or Insulin
|
|---|---|---|
|
Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population
|
8.4 10^-9 min^-1
Standard Error 2.07
|
1.4 10^-9 min^-1
Standard Error 1.98
|
Adverse Events
Dapagliflozin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dapagliflozin
n=50 participants at risk
Dapagliflozin + Metformin or Insulin
|
Placebo
n=50 participants at risk
Placebo + Metformin or Insulin
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
6.0%
3/50 • Number of events 3
|
6.0%
3/50 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution \& PI agree they will not use or disclose and confidential information to third parties for a period of 10 years from receipt
- Publication restrictions are in place
Restriction type: OTHER