- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02947503
Pregnancy Outcomes: Effects of Metformin Study (POEM Study) (POEM)
Pregnancy Outcomes: Effects of Metformin Study (POEM Study), a Long Term Randomized Controlled Study in Gestational Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Adriaan Kooy, Dr
- Phone Number: +31528286859
- Email: a.kooy@treant.nl
Study Contact Backup
- Name: Louise Smit
- Email: l.ismit@treant.nl
Study Locations
-
-
-
Groningen, Netherlands
- Recruiting
- University Medical Center Groningen
-
Groningen, Netherlands
- Recruiting
- Martini Hospital Groningen
-
Hoogenveen, Emmen, Stadskanaal, Netherlands
- Recruiting
- Treant Zorggroep
-
Leeuwarden, Netherlands
- Recruiting
- Medical Center Leeuwarden
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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. |
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.
Other Names:
|
No Intervention: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GDM Outcome Score (GOS) in Phase A
Time Frame: 30 months
|
An aggregate score of eight clinically relevant endpoints, as previously defined:
|
30 months
|
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
|
42 months
|
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
|
282 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Outcome measures phase A mother
Time Frame: 30 months
|
Maternal outcome score (MOS)
For each individual component applies: if occured=1 point. If not occured =0 points. A total score per individual will be calculated (0-5 for MOS). Each component on its own is also a secondary outcome measure. |
30 months
|
Secondary Outcome measures phase A child
Time Frame: 30 months
|
Neonatal outcome score (NOS)**
For each individual component applies: if occured=1. If not occured=0. A total score per individual will be calculated (0-11 for NOS). Each component on its own is also a secondary outcome measure. Apgar score as a variable (1-10) at 1, 5, 10 min Foetal weight at delivery in grams |
30 months
|
Secondary outcome measures phase B
Time Frame: 42 months
|
Hypertension development (yes/no) Thrombotic and CVD events (yes/no) Development of chronic disease (according to list - yes/no) Gonadal and gender development (to be determined: question(naires) + potentially additional measurements from research blood panel) Puberty and maturation (to be determined: question(naires) + potentially additional measurements from research blood panel) Educational and intellectual development (levels of education completed) Development of chronic disease (according to list - yes/no) |
42 months
|
Secondary outcome measures phase C
Time Frame: 282 months
|
Hypertension development (yes/no) Thrombotic and CVD events (yes/no) Development of chronic disease (according to list - yes/no) Gonadal and gender development (to be determined: question(naires) + potentially additional measurements from research blood panel) Puberty and maturation (to be determined: question(naires) + potentially additional measurements from research blood panel) Educational and intellectual development (levels of education completed) Development of chronic disease (according to list - yes/no) |
282 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Adriaan Kooy, Dr., BDRC
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL 2016 POEMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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