Insulin-dependent Gestational Diabetes Clinical Trial
Official title:
A Phase II, Randomized, Double-blind, 2-arm Controlled Study to Evaluate Efficacy of the DPPIV-inhibitor Vildagliptin for Prevention of Type 2 Diabetes in Women With a Recent History of Insulin-requiring Gestational Diabetes
The aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily
dose of 100 mg in scope of the development of type 2 diabetes in women with insulin
dependent gestational diabetes in their last pregnancy not longer than 9 months after birth.
In this randomized, placebo-controlled, double-blinded clinical phase II study, 140
participants aged 18 years or older and an insulin dependent gestational diabetes in their
last pregnancy should be included and treated with vildagliptin or placebo over 24 months,
followed by a 12 months observation period. Exclusion criteria are pregnancy and lactation
as well as a clinical overt diabetes or islet autoimmunity.
The null hypothesis is that there is no significant difference of diabetes incidence
(according to ADA criteria 1997) in both groups.
Primary endpoint is the clinical manifestation of diabetes, secondary endpoints include the
improvement of beta cell function (evaluable by C-peptide measurement) and of insulin
sensitivity by the treatment with vildagliptin.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment