Metformin Versus Insulin in Gestational Diabetes
- Registration Number
- NCT01240785
- Lead Sponsor
- Turku University Hospital
- Brief Summary
Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).
- Detailed Description
Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications). The study was performed as a randomized controlled trial in one center, Turku University hospital using the non-inferiority design in June 2006 - December 2010. The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 221
- Mothers with gestational diabetes who had at least twice plasma glucose at fasting > 5.4 mmol/L and/or 1 hour postprandial value > 7.7 mmol/L at 24 to 32 gestational weeks
- Fasting glucose > 7.0 mmol/L or 1 hour postprandial plasma glucose > 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) > 7.0%
- Renal, hepatic or cardiac failure
- Pregestational use of metformin
- Pregnancy with multiple fetuses
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description insulin insulin NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values Metformin metformin Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values
- Primary Outcome Measures
Name Time Method Birth Weight Per Arm delivery birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies
- Secondary Outcome Measures
Name Time Method Pregnancy Induced Hypertension Per Arm up to on the average 40 weeks of gestation Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure \> 30 mmHg or diastolic blood pressure \> 15 mmHg
Maternal Weight Gain Per Arm up to on the average 40 weeks of gestation Pre-eclampsia Per Arm up to on the average 40 weeks of gestation Mode of Delivery Per Arm delivery Gestational Weeks at Delivery Per Arm delivery Induction of Delivery Per Arm delivery Shoulder Dystocia Per Arm delivery Neonatal Hypoglycemia Per Arm 0-24 h after delivery Neonatal Hyperbilirubinemia Per Arm 0-3 days after delivery Apgar Score at 5 Min After Delivery Per Arm 5 minutes after delivery Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome
Neonate Transfer to Intensive Care Unit Per Arm 0-5 days after delivery Child Outcome at 2 Years Per Arm 2 years after birth neuropsychological and motor skills testing