Sitagliptin + Metformin Compared to Metformin Monotherapy and Placebo in Women With a Recent GDM
Status:
Completed
Trial end date:
2017-09-28
Target enrollment:
Participant gender:
Summary
Gestational diabetes mellitus (GDM) is defined as "any degree of glucose intolerance with
onset or first recognition during pregnancy." GDM is one of the most frequent metabolic
disorders occurring during pregnancy. Approximately 7% of all pregnancies in the United
States are complicated by gestational diabetes resulting in more than 200,000 cases annually.
There is epidemiologic evidence associating GDM with insulin resistance, glucose intolerance,
and type 2 diabetes (DM2). Among all the risk factors of diabetes mellitus, the experience of
gestational diabetes is the strongest one. Systematic reviews of older studies conclude that
35-60% women with gestational diabetes will develop type 2 diabetes at rates much greater
than control groups who did not have glucose intolerance during pregnancy. Studies are needed
for optimal postpartum and long-term health of women who have had GDM. Recent evidence
suggests that incretin-based therapies may be useful for the treatment of DM2 because
continuous administration of glucagon-like peptide 1 (GLP-1) produces substantial
improvements in glucose control and ß-cell function in subjects with DM2. Inhibition of
dipeptidyl peptidase-4 (DPP-4) increases the concentration of GLP-1 and may potentially delay
disease progression in GDM considering the ß-cell function improvement in DM2 and ß-cell mass
shown to increase in animal models. This study will examine if combination sitagliptin (a
DPP-4 inhibitor)-plus metformin is more effective than metformin alone or placebo in
improving metabolic parameters, specifically the impact on β-cell function, in prior GDM
women with glucose abnormalities.
Phase:
Phase 4
Details
Lead Sponsor:
Woman's
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Dipeptidyl-Peptidase IV Inhibitors Metformin Sitagliptin Phosphate