Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

Phase 2/3 Completed 97 enrolled University of Oulu

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2005-06
Primary completion: 2009-08
Completion: 2009-10

Outcome

Missed primary endpoint

paper There were no statistically significant differences in the incidence of LGA (8.5 versus 10.0%, P = 0.97), mean birthweight, mean cord artery pH or neonatal morbidity between the insulin and metformin groups. PMID 21083860 ↗

Publications

Ijas H, Vaarasmaki M, Morin-Papunen L, Keravuo R, Ebeling T, Saarela T, Raudaskoski T. Metformin should be considered in the treatment of gestational diabetes: a prospective randomised study. BJOG. 2011 Jun;118(7):880-5. doi: 10.1111/j.1471-0528.2010.02763.x. Epub 2010 Nov 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Insulin	Protein / enzyme biologic	—	—
Subject	Metformin	Small molecule	—	Oral