NCT02947503: POEM

Pregnancy Outcomes: Effects of Metformin Study (POEM Study), a Long Term Randomized Controlled Study in Gestational Diabetes

Recruiting now Phase 3 Last updated 7 February 2022

What this trial tests

Phase 3 trial testing Metformin TEVA 850 mg in Gestational Diabetes in 500 participants. Currently enrolling.

Timeline

26 November 2019

Primary endpoint
1 December 2043

1 December 2043

Quick facts

Lead sponsor	Bethesda Diabetes Research Center
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	500
Start date	26 November 2019
Primary completion	1 December 2043
Estimated completion	1 December 2043
Sites	4 locations across Netherlands

Drugs / interventions tested

• Metformin TEVA 850 mg — full drug profile →

Conditions studied

• Gestational Diabetes — all drugs for Gestational Diabetes →
• Insulin Resistance — all drugs for Insulin Resistance →

Sponsor

Bethesda Diabetes Research Center — full company profile →

Who can join

Adults 18 to 45, female only, with Gestational Diabetes or Insulin Resistance. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• GDM Outcome Score (GOS) in Phase A
  Time frame: 30 months
  An aggregate score of eight clinically relevant endpoints, as previously defined: 1. pregnancy related hypertension, including (pre-) eclampsia, according validated guidelines, 2. large for gestational age baby (LGA) at delivery according validated guidelines, 3. premature delivery with a gestational age \< 37 weeks, 4. instrumental delivery, 5. caesarean delivery, 6. birth trauma, like fractures
• T2D and obesity at the end of Phase B
  Time frame: 42 months
  Incidence of maternal T2DM Weight (kg) and BMI (category) development mother Weight (kg) and BMI (percentile) development child
• Development of T2D and obesity during Phase C
  Time frame: 282 months
  Incidence of maternal T2DM Weight (kg) and BMI (category) development mother Weight (kg) and BMI (percentile) development child

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Long-Term Effects of Oral Antidiabetic Drugs During Pregnancy on Offspring: A Systematic Review and Meta-analysis of Follow-up Studies of RCTs.
   van Weelden W, Wekker V, de Wit L, Limpens J, et al · · 2018 · cited 33× · PMID 30168045 · DOI 10.1007/s13300-018-0479-0
2. Pregnancy Outcomes: Effects of Metformin (POEM) study: a protocol for a long-term, multicentre, open-label, randomised controlled trial in gestational diabetes mellitus.
   van Hoorn EGM, van Dijk PR, Prins JR, Lutgers HL, et al · · 2022 · cited 2× · PMID 35354633 · DOI 10.1136/bmjopen-2021-056282
3. The Impact of Conservative Versus Pharmacological Management on Maternal and Neonatal Outcomes in Gestational Diabetes: A Systematic Review and Meta-Analysis.
   Ikwuanusi E, Yafai I, Emovon E. · · 2025 · PMID 41246621 · DOI 10.7759/cureus.94610