Pregnancy Outcomes: Effects of Metformin Study (POEM Study)

Summary

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 persistent obesity, in mother and child. Moreover, insulin added to diet as the standard care for GDM has disadvantages for mother (maintenance of hyperinsulinaemia, increasing weight and blood pressure) and child (macrosomia, hypoglycaemia) with related adverse pregnancy outcomes. Metformin, as an insulin sensitizer targeting the cause of GDM, may have essential benefits, as suggested by observational studies. However, RCTs with metformin (early positioned in the treatment of GDM) are still lacking. The POEM study is the first Randomized controlled trial (RCT) in GDM to test the hypothesis that metformin, early given from the start of the diagnosis GDM, on top of diet and lifestyle improves clinically relevant pregnancy outcomes in mother and child during pregnancy, at delivery and on the longer term - up to 20 years after birth.

Conditions

• Gestational Diabetes
• Insulin Resistance

Interventions

DRUG

Metformin TEVA 850 mg

At inclusion, patients (N=500) will be randomized 1:1 to metformin vs usual care (850 mg tablets, 3 times daily or, if tolerance is suboptimal, a lower maximally tolerated dose, 1-2 times daily), on top of diet and lifestyle, with an insulin rescue in both arms if needed.

Sponsors & Collaborators

• Maastricht University Medical Center

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Frisius Medisch Centrum

  collaborator OTHER

• Martini Hospital Groningen

  collaborator OTHER

• Treant Zorggroep

  collaborator UNKNOWN

• Nij Smellinghe Hosptial

  collaborator OTHER

• Bethesda Diabetes Research Center

  lead OTHER

Principal Investigators

• Adriaan Kooy, Dr. · BDRC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-26

Primary Completion

2043-12-31

Completion

2043-12-31

Countries

• Netherlands

Study Locations