Gestational Diabetes MellitusPhase 3Medico-GDMNCT02275845
Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus
A Phase 3 study testing Metformin in people with Gestational Diabetes Mellitus, run by Maasstad Hospital at 1 site in Netherlands.
Trial summary
Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial' The Medico-GDM trial Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Oct 2014to 3 Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- a subject must meet all of the following criteria:
- high risk (according to ductch national criteria) for gestational diabetes
- aged between 18 and 40 years
- gestational age between 8 and 12 weeks
- and able to communicate and read in Dutch.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- no singleton pregnancy judged by ultrasonography
- diagnosis of diabetes mellitus before the current pregnancy-
- high fasting glucose at first trimester (> 5.3 mmol/l)
- cardiac insufficiency-\
- renal insufficiency (MDRD < 60)
- liver disease
- use of medication other than Paracetamol or vitamins and incompetent women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metformin vs Control to Prevent Gestational Diabetes Mellitus (GDM) in Women With a High Risk for GDM, an Open Label Randomized Controlled Trial, The Medico-GDM Trial
Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial' The Medico-GDM trial
Read the detailed description
Rationale: GDM is a frequent pregnancy complication1 and associated with complications for mother and child.2 At present, the drug of choice for treatment of GDM is Insulin.3 In the last years several studies documented the use of oral blood glucose lowering medication in GDM. Metformin is an accepted alternative for insulin, with comparable glycemic control and neonatal outcomes.4 In studies with women with polycystic ovarian syndrome (PCOS) who received Metformin during pregnancy, the incidence of GDM is less compared to pregnant women with PCOS without Metformin. These studies were however small and there was no adequate control group.5 Our aim is to study the effect of Metformin on the incidence of GDM in women with a high risk for GDM.
Objective: the primary objective is to compare metformin versus no intervention for incidence of GDM in women with a high risk for GDM. The main secondary objective is pregnancy outcome with Metformin, neonatal outcomes and neonatal complications.
Study design: 2 years open label randomized controlled trial, comparing metformin versus control group.
Study population: pregnant women with a high risk of GDM between 18 and 40 years old in the first trimester of pregnancy.
Intervention: the first group receives Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg. The second group receives no intervention. All the subjects are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.
Main study parameters/endpoints: the main study parameter is the difference in incidence of GDM between the two groups.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the subjects will visit our centre for the first time between 12 and 14 weeks of pregnancy, then blood samples will be collected. Further on they will visit our centre at 24 weeks to perform an oral glucose tolerance test (OGTT). Women with GDM in history will perform an OGTT at 16 weeks for the first time. If the OGTT is borderline normal, it will repeated every 4 weeks. This is according to current Dutch guidelines3, without any extra discomfort for study participants. The subjects will visit their own gynaecologist or obstretican for their regular pregnancy controls. Metformin is not officially registered for use in pregnancy. Long term effects for the unborn child are not known. However, previous studies did not found neonatal and pregnancy related complications.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Metformin, control diet
- Keywords
- metformin, prevention
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg (from 14 weeks pregnancy untill delivery)
control dietOther
2000 calories/day diet, with an adequate distribution of carbohydrates during the day
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg. All the subjects are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day. Receives: Drug: Metformin; Other: control diet |
| control diet | Active comparator | a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day. Receives: Other: control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of gestational diabetes mellitus in both groups
Measured: from 14 weeks pregnancy untill delivery
Secondary outcomes (2)
Maternal outcomes
Maternal: pregnancy induced hypertension (yes vs no: systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), weight gain during pregnancy (kg), abnormal glucose daily curve after pregnancy (yes vs no: measurement of blood glucose concentration seven times daily).), insulin therapy required.
Measured: from 14 weeks pregnancy untill delivery
Neonatal outcomes
head circumference (cm), birth weight (g) and height (cm), pH of umbilical-cord.
Neonatal complications: serious neonatal complications (including: severe birth defects, stillbirth, birth trauma, respiratory distress, admission to neonatal intensive care unit, low 5-minutes Apgar score (< 7) and premature birth (< 37 weeks of gestation)), neonatal hypoglycaemia that requires therapy, need for phototherapy, small for gestational age (birth weight < 2 SD units), birth weight > 90th percentile, birth weight < 10th percentile.
Measured: from 14 weeks pregnancy untill delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study start8 Oct 2014
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wetenschapsbureau, Maasstad Hospital
- Investigators
- Joke van der Linden, dr., Principal investigator, Maasstad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275845
- Sponsor's protocol ID
- NL48005.101.15
- Other IDs
- 2014-000446-30, 2014
- Acronym
- Medico-GDM
- Status last verified
- Dec 2015
- First submitted
- 23 Oct 2014
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin vs Control to Prevent Gestational Diabetes Mellitus (GDM) in Women With a High Risk for GDM, an Open Label Randomized Controlled Trial, The Medico-GDM Trial
- ClinicalTrials.gov ID
- NCT02275845
- Acronym / sponsor ID
- Medico-GDM / NL48005.101.15
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- metformin, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- 8 Oct 2014 (actual)
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial' The Medico-GDM trial
Detailed description
Rationale: GDM is a frequent pregnancy complication1 and associated with complications for mother and child.2 At present, the drug of choice for treatment of GDM is Insulin.3 In the last years several studies documented the use of oral blood glucose lowering medication in GDM. Metformin is an accepted alternative for insulin, with comparable glycemic control and neonatal outcomes.4 In studies with women with polycystic ovarian syndrome (PCOS) who received Metformin during pregnancy, the incidence of GDM is less compared to pregnant women with PCOS without Metformin. These studies were however small and there was no adequate control group.5 Our aim is to study the effect of Metformin on the incidence of GDM in women with a high risk for GDM.
Objective: the primary objective is to compare metformin versus no intervention for incidence of GDM in women with a high risk for GDM. The main secondary objective is pregnancy outcome with Metformin, neonatal outcomes and neonatal complications.
Study design: 2 years open label randomized controlled trial, comparing metformin versus control group.
Study population: pregnant women with a high risk of GDM between 18 and 40 years old in the first trimester of pregnancy.
Intervention: the first group receives Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg. The second group receives no intervention. All the subjects are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.
Main study parameters/endpoints: the main study parameter is the difference in incidence of GDM between the two groups.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the subjects will visit our centre for the first time between 12 and 14 weeks of pregnancy, then blood samples will be collected. Further on they will visit our centre at 24 weeks to perform an oral glucose tolerance test (OGTT). Women with GDM in history will perform an OGTT at 16 weeks for the first time. If the OGTT is borderline normal, it will repeated every 4 weeks. This is according to current Dutch guidelines3, without any extra discomfort for study participants. The subjects will visit their own gynaecologist or obstretican for their regular pregnancy controls. Metformin is not officially registered for use in pregnancy. Long term effects for the unborn child are not known. However, previous studies did not found neonatal and pregnancy related complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Drug: Metformin, Other: control dietMetformin twice daily 500 mg for the first week, after that twice daily 1000 mg. All the subjects are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day. |
| control diet | Active comparator | Other: control dieta diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- high risk (according to ductch national criteria) for gestational diabetes
- aged between 18 and 40 years
- gestational age between 8 and 12 weeks
- and able to communicate and read in Dutch.
Key exclusion criteria (8 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- no singleton pregnancy judged by ultrasonography
- diagnosis of diabetes mellitus before the current pregnancy-
- high fasting glucose at first trimester (> 5.3 mmol/l)
- cardiac insufficiency-\
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminMetformin twice daily 500 mg for the first week, after that twice daily 1000 mg (from 14 weeks pregnancy untill delivery) | Drug | intervention |
| control diet2000 calories/day diet, with an adequate distribution of carbohydrates during the day | Other | control diet, intervention |
Primary outcome
incidence of gestational diabetes mellitus in both groups
Time frame: from 14 weeks pregnancy untill delivery
2 secondary outcomes
Maternal outcomes
Time frame: from 14 weeks pregnancy untill delivery
Neonatal outcomes
Time frame: from 14 weeks pregnancy untill delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joke van der Linden, dr. principal investigator
Maasstad Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Gestational Diabetes Mellitus, run by Maasstad Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of gestational diabetes mellitus in both groups (time frame: from 14 weeks pregnancy untill delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.