NCT01240785

Metformin Versus Insulin in Gestational Diabetes

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DRUG	metformin	metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
DRUG	insulin	subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-01-01
• Completion: 2012-12-01
• First posted: 2010-11-15
• Last updated: 2014-11-24
• Results posted: 2014-11-24