Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

Gestational Diabetes Mellitus Clinical Trial

Official title:

Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087866
• Other study ID #: 070471
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 15, 2010
• Last updated: March 15, 2010
• Start date: June 2005
• Est. completion date: October 2009

Study information

• Verified date: March 2010
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Drug:
• Metformin

• Insulin

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of fetal macrosomy