Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

Phase 2

Completed

• Conditions: Gestational Diabetes Mellitus
• Interventions: Drug: Metformin; Drug: Insulin

• Registration Number: NCT01087866
• Lead Sponsor: University of Oulu

Brief Summary

The purpose of this study is to determine if metformin therapy prevents fetal macrosomy in gestational diabetes mellitus to the same extent as insulin therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2009-08
• Study Completion: 2009-10
• Status Verified: 2010-03
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Last Update Submitted: 2010-03-15
• Study First Posted: 2010-03-16
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

Inclusion Criteria

• gestational diabetes mellitus diagnosed between 12-34 pregnancy weeks if normoglycemia is not reached with diet

Exclusion Criteria

• hypertension with pharmacological treatment or preeclampsia
• multiple pregnancy
• liver or kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	-
Insulin	Insulin	-

Primary Outcome Measures

Name	Time	Method
Percentage of fetal macrosomy

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland