Conditions: Gestational Diabetes
Keywords: gestational diabetes metformin insulin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 221
Healthy volunteers: no

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.

Arms:
arm 1: Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values arm 2: NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values

Interventions: intervention 1: metformin intervention 2: insulin
Intervention descriptions: intervention 1: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily intervention 2: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery

Protocol document: