Trial Outcomes & Findings for Dapagliflozin and Metformin,Alone and in Combination, in Overweight/Obese Prior GDM Women (NCT NCT02338193)
NCT ID: NCT02338193
Last Updated: 2019-06-11
Results Overview
Change in absolute body weight with combination therapy compared to monotherapy from baseline to week 24
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
69 participants
Primary outcome timeframe
Change from baseline (time 0) to study end (24 weeks)
Results posted on
2019-06-11
Participant Flow
Patients recruited from Woman's Hospital post delivery
3 patients not randomized since reluctant to take medication
Participant milestones
| Measure |
DAPA/MET XR
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
25
|
|
Overall Study
COMPLETED
|
17
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
10
|
Reasons for withdrawal
| Measure |
DAPA/MET XR
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
1
|
|
Overall Study
Noncompliant with visits
|
2
|
2
|
7
|
|
Overall Study
moved out of state
|
0
|
1
|
0
|
|
Overall Study
intolerant of side effects
|
1
|
0
|
0
|
Baseline Characteristics
Dapagliflozin and Metformin,Alone and in Combination, in Overweight/Obese Prior GDM Women
Baseline characteristics by cohort
| Measure |
DAPA/MET XR
n=20 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=21 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=25 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
25 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
BMI greater than/equal to 25
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline (time 0) to study end (24 weeks)Change in absolute body weight with combination therapy compared to monotherapy from baseline to week 24
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Change in Body Weight
|
-21.5 kilograms
Standard Deviation 14
|
-12.5 kilograms
Standard Deviation 20
|
-4.4 kilograms
Standard Deviation 18
|
SECONDARY outcome
Timeframe: Change from baseline (time 0) to study end (24 weeks)Change in percent body weight with combination therapy compared to monotherapy from baseline to week 24
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Change in Percent Body Weight
|
-4.9 percent weight loss from baseline
Standard Deviation 3.1
|
-3.2 percent weight loss from baseline
Standard Deviation 4.5
|
-1.1 percent weight loss from baseline
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentBMI (measure of overall adiposity) in combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Body Mass Index (BMI)
|
33 kg/m2
Standard Deviation 6.2
|
33.7 kg/m2
Standard Deviation 7.7
|
31 kg/m2
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentWaist size (measure of truncal adiposity)with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Waist Circumference (WC)
|
95.6 centimeters
Standard Deviation 12.7
|
95 centimeters
Standard Deviation 16.6
|
91.7 centimeters
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentWaist-to-hip ratio with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Waist- to -Hip Ratio (WHR; Measure of Central Adiposity)
|
0.81 Ratio
Standard Deviation 0.055
|
0.80 Ratio
Standard Deviation .06
|
0.83 Ratio
Standard Deviation .06
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentWaist divided by height a( measure of central adiposity) with combination therapy compared to monotherapy after 24 weeks of therapy
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Waist-to-height Ratio (WHtR)
|
0.58 ratio
Standard Deviation .06
|
0.57 ratio
Standard Deviation .09
|
0.56 ratio
Standard Deviation .06
|
SECONDARY outcome
Timeframe: 24 weeks of treatment)Diastolic blood pressure with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Diastolic Blood Pressure (DBP)
|
79 mmHG
Standard Deviation 11
|
77.8 mmHG
Standard Deviation 11
|
79 mmHG
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentSystolic blood pressure with combination therapy compared to monotherapy after 24 weeks of therapy
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Systolic Blood Pressure (SBP)
|
125 mmHg
Standard Deviation 12
|
124 mmHg
Standard Deviation 13
|
119.6 mmHg
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentALT/AST ratio with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Liver Enzymes
|
1.13 Ratio
Standard Deviation .35
|
1.12 Ratio
Standard Deviation .32
|
1.18 Ratio
Standard Deviation .3
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentCholesterol levels with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Total Cholesterol Levels (CHOL)
|
196 mg/dL
Standard Deviation 45
|
168 mg/dL
Standard Deviation 32
|
178 mg/dL
Standard Deviation 31
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTriglyceride levels with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Triglyceride (TRG) Levels
|
119 mg/dL
Standard Deviation 59
|
89.8 mg/dL
Standard Deviation 39
|
212 mg/dL
Standard Deviation 64
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentFasting blood glucose levels with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Fasting Blood Glucose (FBG)
|
89 mg/dL
Standard Deviation 7.9
|
91 mg/dL
Standard Deviation 9.2
|
87 mg/dL
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentMean blood glucose after glucose load with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Mean Blood Glucose (MBG) During an OGTT
|
109.5 mg/dL
Standard Deviation 15.2
|
110.1 mg/dL
Standard Deviation 17.8
|
112.5 mg/dL
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentHOMA index of insulin resistance calculated from fasting insulin and glucose with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Fasting Insulin Sensitivity (HOMA-IR)
|
2.6 Index
Standard Deviation 1.6
|
2.4 Index
Standard Deviation 1.4
|
1.8 Index
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentSurrogate measure of insulin sensitivity derived from OGTT with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Matsuda Sensitivity Index (SI OGTT)
|
6.0 Index
Standard Deviation 3.2
|
6.3 Index
Standard Deviation 4.4
|
5.42 Index
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentCorrected early insulin response to glucose challenge \[(insulinogenic index (IGI)/ divided by fasting insulin resistance index (HOMA-IR)\] with combination therapy compared to monotherapy after 24 weeks of treatment
Outcome measures
| Measure |
DAPA/MET XR
n=17 Participants
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=17 Participants
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=15 Participants
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
First Phase Insulin Secretion (IGI/HOMA-IR)
|
1.7 Index
Standard Deviation 3.2
|
1.1 Index
Standard Deviation 1.2
|
0.77 Index
Standard Deviation .53
|
Adverse Events
DAPA/MET XR
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dapaglifloxin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Metformin XR
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DAPA/MET XR
n=20 participants at risk
Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks
DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
|
Dapaglifloxin
n=21 participants at risk
Dapagliflozin- 10 mg once daily before first meal for 24 weeks
DAPA: 10 mg dapagliflozin QD for 20-24 weeks
|
Metformin XR
n=25 participants at risk
Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks
MET XR: 1000 mg Metformin XR BID for 20-24 weeks
|
|---|---|---|---|
|
Renal and urinary disorders
Yeast infection
|
25.0%
5/20 • Number of events 5 • 6 months while participating in trial
|
28.6%
6/21 • Number of events 6 • 6 months while participating in trial
|
0.00%
0/25 • 6 months while participating in trial
|
|
Gastrointestinal disorders
Nausea/diarrhea
|
5.0%
1/20 • Number of events 1 • 6 months while participating in trial
|
0.00%
0/21 • 6 months while participating in trial
|
20.0%
5/25 • Number of events 5 • 6 months while participating in trial
|
Additional Information
Dr Karen Elkind-Hirsch, Director of Research
Woman's Hospital
Phone: 225 231-5278
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place