PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)

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.

Intervention(s) in this Clinical Trial

• Drug: vildagliptin
  • 100 mg per day over 24 months
• Drug: inactive pill
  • 1 pill per day over 24 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: vildagliptin
• 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.

Primary Measures

• development of type 2 diabetes mellitus by criteria of ADA 1997
  • Time Frame: 3 years
    Safety Issue?: No

Inclusion Criteria:

• women with insulin-dependent gestational diabetes during the last pregnancy
• < 9 months after delivery
• age 18 years or older
• contraception during intervention period (at least 24 months)

Exclusion Criteria:

• pregnancy or lactation
• GADA or IA-2A positivity
• clinical overt diabetes

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Institut fur Diabetesforschung, Munich, Germany Other

Overall Clinical Trial Officials and Contacts

Overall Contact: Anette G Ziegler, MD +49 (0)89 3068 2917 anziegler@lrz.uni-muenchen.de

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018602

Study ID Number: 808040006

ClinicalTrials.gov Identifier: NCT01018602

Health Authority: Germany: Federal Institute for Drugs and Medical Devices