Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus

Maasstad Hospital

Status and phase

Unknown

Phase 3

Conditions

Gestational Diabetes Mellitus

Treatments

Drug: Metformin

Other: control diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02275845

NL48005.101.15

2014-000446-30 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

400 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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 design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

intervention

Experimental group

Description:

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.

Treatment:

Drug: Metformin

Other: control diet

control diet

Active Comparator group

Description:

a diet which contains a 2000 calories/day diet, with an adequate distribution of carbohydrates during the day.

Treatment:

Other: control diet