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Clinical Trial Details

Trial ID: L6979
Source ID: NCT02338193
Associated Drug: Dapa/Met Xr
Title: Dapagliflozin and Metformin,Alone and in Combination, in Overweight/Obese Prior GDM Women
Acronym: DAPA-GDM
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02338193/results
Conditions: Diabetes Prevention in Women After GDM Who Are at High-risk
Interventions: DRUG: DAPA/MET XR|DRUG: DAPA|DRUG: MET XR
Outcome Measures: Primary: Change in Body Weight, Change in absolute body weight with combination therapy compared to monotherapy from baseline to week 24, Change from baseline (time 0) to study end (24 weeks) | Secondary: Change in Percent Body Weight, Change in percent body weight with combination therapy compared to monotherapy from baseline to week 24, Change from baseline (time 0) to study end (24 weeks)|Body Mass Index (BMI), BMI (measure of overall adiposity) in combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|Waist Circumference (WC), Waist size (measure of truncal adiposity)with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|Waist- to -Hip Ratio (WHR; Measure of Central Adiposity), Waist-to-hip ratio with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|Waist-to-height Ratio (WHtR), Waist divided by height a( measure of central adiposity) with combination therapy compared to monotherapy after 24 weeks of therapy, 24 weeks of treatment|Diastolic Blood Pressure (DBP), Diastolic blood pressure with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment)|Systolic Blood Pressure (SBP), Systolic blood pressure with combination therapy compared to monotherapy after 24 weeks of therapy, 24 weeks of treatment|Liver Enzymes, ALT/AST ratio with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|Total Cholesterol Levels (CHOL), Cholesterol levels with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|Triglyceride (TRG) Levels, Triglyceride levels with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|Fasting Blood Glucose (FBG), Fasting blood glucose levels with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|Mean Blood Glucose (MBG) During an OGTT, Mean blood glucose after glucose load with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|Fasting Insulin Sensitivity (HOMA-IR), HOMA index of insulin resistance calculated from fasting insulin and glucose with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|Matsuda Sensitivity Index (SI OGTT), Surrogate measure of insulin sensitivity derived from OGTT with combination therapy compared to monotherapy after 24 weeks of treatment, 24 weeks of treatment|First Phase Insulin Secretion (IGI/HOMA-IR), Corrected 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, 24 weeks of treatment
Sponsor/Collaborators: Sponsor: Woman's | Collaborators: AstraZeneca
Gender: FEMALE
Age: ADULT
Phases: PHASE3
Enrollment: 69
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-09-22
Completion Date: 2019-03-13
Results First Posted: 2019-04-30
Last Update Posted: 2019-06-11
Locations: Woman's Hospital, Baton Rouge, Louisiana, 70815, United States
URL: https://clinicaltrials.gov/show/NCT02338193