drugset / Trial / NCT01234649

Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM)

NCT01234649

Phase 3 Completed 153 enrolled Woman's Novo Nordisk A/S · collab
RandomizedParallel-groupTriple-blindPrevention

Summary

A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future health of the mother. GDM is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes (DM2) at rates much greater than control groups who did not have glucose intolerance during pregnancy. Liraglutide may potentially delay disease progression in GDM considering the beta -(ß-)cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if the addition of liraglutide to metformin therapy is more effective than metformin alone in improving insulin sensitivity and normalizing insulin secretion in at-risk overweight/obese women with prior GDM.

Timeline

Start
2011-08-11
Primary completion
2019-04-24
Completion
2019-06-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide 1.8 mg Subcutaneous
Comparator Metformin Small molecule 1000 mg