CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 114 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 850 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01280409
NCT01280409Phase 4Completed
CompareCT.gov

The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial

The University of Texas Health Science Center, Houston·interventional·Posted Jan 20, 2011·Updated Nov 28, 2018

In Brief

A Phase 4 clinical trial evaluating Metformin and Placebo for Diabetes, Gestational. Completed, enrolled 114 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine whether the study drug metformin is helpful in reducing weight after pregnancy in women with gestational diabetes. This pilot study will provide information on how well women are able to take metformin postpartum, whether metformin increases weight loss, and whether there are any increased risks of side effects to you as a new mother.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Gestational
CountriesUnited States
CollaboratorsGilstrap, Larry C, M.D.

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2011
Enrollment StartJan 1, 2011
Primary CompletionMar 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.5 years ago

Interventions

Metformindrug

Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks

Placebodrug

Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.