Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Woman's. The registered enrollment target is 69 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02338193
The ClinicalTrials.gov registry entry for NCT02338193 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Woman's, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which DAPA/MET XR is the first listed.
NCT02338193 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.