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NCT02338193 · ClinicalTrials.gov registry record · Phase 3
Dapagliflozin and Metformin,Alone and in Combination, in Overweight/Obese Prior GDM Women
A Phase 3 study, sponsored by Woman's.
- Completed
- Registry status
- Phase 3
- Development phase
- 69
- Enrollment target
NCT02338193: Completed Phase 3 study, sponsored by Woman's.
NCT02338193 is a Phase 3 study that has completed, run by Woman's. The registered enrollment target is 69 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02338193, a Phase 3 study, has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 69 participants
- Enrollment target
Study Summary
Women with a history of gestational diabetes (GDM) are at substantially increased risk of type 2 diabetes mellitus (T2DM). Compared with the general population, these women are more likely to be overweight or obese. Moreover, weight gain after GDM is significantly associated with T2DM, independent of baseline body weight. Weight gain, particularly increased central adiposity after delivery, is strongly associated with deterioration of β-cell compensation for insulin resistance. Taken together, our findings and other studies support increased abdominal fat as the strongest factor associated with declining B-cell compensation for insulin resistance in prior GDM women at high risk for T2DM. Dapagliflozin is a novel highly selective SGLT2 inhibitor that improves glycemic control by reducing renal glucose reabsorption leading to urinary glucose excretion. Its efficacy and safety has been studied in multiple randomized controlled trials including an add-on to metformin compared with a placebo. To the extent that glucotoxicity contributes to the demise in β-cell function in subjects with impaired glucose, SGLT2 inhibitors also may prove useful in the treatment of "prediabetes." An additional secondary benefit of SGLT2 inhibition is the elimination of calories in the form of glucose. The loss of glucose with attendant caloric loss contributes to weight loss; in addition, improvements in β cell function have been seen. Weight loss seen with SGLT2 inhibitors is similar to that seen with glucagon-like peptide 1 analogs, and may be more acceptable because they are oral agents. A consistent finding in all dapagliflozin studies has been a reduction in blood pressure. The investigators hypothesize that combination dapagliflozin -metformin treatment over a 24-week period will have a greater positive impact on body weight, anthropometric measurements and glycemic and cardiometabolic parameters than dapagliflozin or metformin monotherapy in overweight/obese at-risk women with a histo
Primary Outcome
Change in absolute body weight with combination therapy compared to monotherapy from baseline to week 24
Interventions
- DRUG DAPA/MET XR
- DRUG DAPA
- DRUG MET XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2015-09-22 |
| Est. Completion | 2019-03-13 |
| Phase | Phase 3 |
What the finished NCT02338193 record still lists
NCT02338193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which DAPA/MET XR is the first listed.
NCT02338193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02338193 about?
NCT02338193 is a clinical study titled "Dapagliflozin and Metformin,Alone and in Combination, in Overweight/Obese Prior GDM Women". Women with a history of gestational diabetes (GDM) are at substantially increased risk of type 2 diabetes mellitus (T2DM). Compared with the general population, these women are more likely to be overweight or obese. Moreover, weight gain after GDM is significantly associated with T2DM, independent o...
What is the current status of trial NCT02338193?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2015-09-22. Estimated completion is 2019-03-13.
What interventions are being tested in trial NCT02338193?
The interventions under investigation include: DAPA/MET XR (DRUG), DAPA (DRUG), MET XR (DRUG).
Who is sponsoring clinical trial NCT02338193?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02338193's enrollment target sits among peer trials
69 1793rd of 2000 higher than 205 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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