Pregnancy Outcomes: Effects of Metformin Study (POEM Study)
Recruiting
Phase 3
Interventional Study
Gestational Diabetes
Insulin Resistance
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 45
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- Bethesda Diabetes Research Center · Other
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About This Trial
One approach to prevent the rising burden of diabetes is to address the issue of gestational diabetes mellitus (GDM). GDM has a growing prevalence up to 5-10% (and even higher in specific subgroups), with a pregnant population becoming older and more obese worldwide. GDM increases the risks of complications during pregnancy, at delivery and on the longer term, like type 2 diabetes (T2D) and persis…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pregnant women with GDM defined as a Fasting Plasma Glucose (FPG) \> 5,3 mMol and/or an Oral Glucose Tolerance test (OGTT) with a Plasma glucose (PG) \> 7,8 mMol, two hours after the oral intake of 75 gram glucose
* Written informed consent
* Age 18-45 years
* Gestational age …
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