PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)
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.
Insulin-dependent Gestational Diabetes
Drug: inactive pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|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|
- development of type 2 diabetes mellitus by criteria of ADA 1997 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: vildagliptin||
100 mg per day over 24 months
Placebo Comparator: inactive pill without active agent
participants receive an inactive pill without active agent, but undergo the same examinations, visits and tests as the group treated with vildagliptin.
Drug: inactive pill
1 pill per day over 24 months
|Contact: Anette G Ziegler, MD||+49 (0)89 3068 2917 ext email@example.com|
|Institut fuer Diabetesforschung||Recruiting|
|Munich, Germany, 80804|
|Contact: Anette G Ziegler, MD +49 (0)89 3068 2917 ext 2917 firstname.lastname@example.org|
|Principal Investigator: Anette G Ziegler, MD|