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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01018602
• Other study ID #: 808040006
• Status: Recruiting
• Phase: Phase 2
• First received: November 20, 2009
• Last updated: June 24, 2011
• Start date: January 2008
• Est. completion date: June 2015

Study information

• Verified date: June 2011
• Source: Institut fur Diabetesforschung, Munich, Germany
• Contact: Anette G Ziegler, MD
• Phone: +49 (0)89 3068 2917
• Email: anziegler[@]lrz.uni-muenchen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Gestational
• Insulin-dependent Gestational Diabetes

Intervention

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

Locations

Country	Name	City	State
Germany	Institut fuer Diabetesforschung	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Institut fur Diabetesforschung, Munich, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of type 2 diabetes mellitus by criteria of ADA 1997		3 years	No