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New treatment option for Gestational Diabetes
Official title Pregnancy Outcomes: Effects of Metformin Study (POEM Study)
ClinicalTrials.gov ID: NCT02947503
What this study is testing
What is Metformin TEVA 850 mg?
Metformin TEVA 850 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gestational diabetes.
Also referred to as Metformin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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)...
- 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)
You likely can't join if
- 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...
- Chronic renal failure with a Glomerular filtration rate (GFR) \< 45 ml/min/1.73m2
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
- Hoogenveen, Emmen, Stadskanaal, Netherlands
- Leeuwarden, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands; Hoogenveen, Emmen, Stadskanaal, Netherlands; Leeuwarden, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.