Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

University of Oulu

Status and phase: Completed; Phase 3; Phase 2

Conditions: Gestational Diabetes Mellitus

Treatments: Drug: Insulin; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01087866

070471

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

Metformin

Experimental group

Treatment:

Drug: Metformin

Insulin

Active Comparator group

Treatment:

Drug: Insulin