Metformin Versus Insulin in Gestational Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Drug: metformin
* Drug: insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values | Drug: metformin<br>* metformin 1 g twice daily or maximum tolerated dose less than 2 g daily<br>* Other names: Diformin retard 500 mg;|
| Active Comparator: insulin<br>NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values | Drug: insulin<br>* subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery<br>* Other names: Humalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth Weight Per Arm | birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies | delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Induced Hypertension Per Arm | 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 | up to on the average 40 weeks of gestation | 
| 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 | 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 | 5 minutes after delivery | 
| Neonate Transfer to Intensive Care Unit Per Arm |  | 0-5 days after delivery | 
| Child Outcome at 2 Years Per Arm | neuropsychological and motor skills testing | 2 years after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, metformin, insulin