Pregnancy Outcomes: Effects of Metformin Study (POEM Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-26

Study Completion Date

2043-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus

NCT02275845

Gestational Diabetes Mellitus

UNKNOWN PHASE3

A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes

NCT05280496

Diabetes, Gestational PreDiabetes Diabetes Mellitus, Type 2

COMPLETED PHASE3

Efficacy of Metformin in Achieving Glycaemia Goals as Recommended for the Treatment of Gestational Diabetes in Non Obese Women

NCT01756105

Gestational Diabetes Metformin Treatment +1 more

TERMINATED PHASE2

Preventing Recurrent Gestational Diabetes With Metformin

NCT02394158

Gestational Diabetes Mellitus

UNKNOWN PHASE4

Towards Precision Medicine for Diabetes in Pregnancy

NCT05932251

Gestational Diabetes Gestational Diabetes Mellitus

SUSPENDED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The POEM study was designed to investigate the effects of metformin on top of diet and lifestyle (with insulin rescue if needed) in GDM on eight clinically relevant pregnancy outcomes at delivery, summarized by means of an integrated, newly developed score, the GDM Outcome Score (GOS), and on other relevant outcomes on the longer term in mother and child. The investigators hypothesize that metformin given to women with GDM from the start of the diagnosis reduces risks resulting in relevant health benefits for mother and child during pregnancy, at delivery, and many years thereafter.

The POEM study is a randomized controlled intervention study, consisting of three phases:

* Phase A - from inclusion until six weeks after delivery; intervention study with and without exposure of metformin in mother and (unborn) child: two arms after randomization with 1:1 allocation to Diet + Lifestyle + Metformin (DLM) or Diet + Lifestyle (DL);
* Phase B - from six weeks until 1 year after delivery; intervention study with exposure of DLM vs DL in mother;
* Phase C - from 1 until 20 years after delivery; observational extension study of mother and child without study medication.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes Insulin Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metformin on top of usual care

Metformin TEVA 850 mg (1-3 times daily) added to usual care from start of the diagnosis GDM.

Usual care has been defined as intensive counselling for diet and lifestyle plus insulin therapy if needed.

Intervention: metformin TEVA 850 mg (1-3 times daily) on top of usual care.

Group Type ACTIVE_COMPARATOR

Metformin TEVA 850 mg

Intervention Type DRUG

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.

Usual care

Usual care from start of the diagnosis GDM. Control group without metformin. Usual care has been defined as intensive counselling for diet and lifestyle plus insulin therapy if needed.

Intervention: usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Metformin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 at inclusion 16-32 weeks
* Glycohemoglobin test (HbA1c) at inclusion ≤ 48 mmol/mol (6.5% Hb)

Exclusion Criteria

* Diabetes mellitus before pregnancy, except previous GDM
* Proteinuria: Urine Albumin-to-Creatinine Ratio (UACR) \> 35 mg/mmol at screening
* Malignancy during the last 5 years before inclusion, except non-melanoma skin cancer
* Psychiatric and/or mood disorder potentially affecting compliance of treatment
* Chronic liver disease and/or Alanine aminotransferase aspartate transaminase (ASAT) and/or Alanine aminotransferase (ALAT) \> 3x Upper Limit of Normal (ULN).
* Chronic renal failure with a Glomerular filtration rate (GFR) \< 45 ml/min/1.73m2
* Chronic pulmonary failure with hypoxia
* Significantly uncontrolled hypertension - Systolic blood pressure (SBP) \> 160 mm Hg despite medical treatment
* Chronic treatment with corticosteroids
* Intolerance for metformin and/or earlier use of metformin in this pregnancy
* Membership of the POEM study group
* Severe foetal anomaly at inclusion - like major neural tube and/or cardiac malformation
* Ruptured membranes
* Multiple pregnancy
* Inability to understand or read the Dutch language
* Bariatric surgery in medical history
* Hyperemesis gravidarum

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No