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

Phase 2

• Conditions: Insulin-dependent Gestational Diabetes
• Interventions: Drug: vildagliptin; Drug: inactive pill

• Registration Number: NCT01018602
• Lead Sponsor: Institut fur Diabetesforschung, Munich, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-11-20
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-24
• Last Update Posted: 2011-06-27
• Primary Completion: 2012-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vildagliptin	vildagliptin	-
inactive pill without active agent	inactive pill	participants receive an inactive pill without active agent, but undergo the same examinations, visits and tests as the group treated with vildagliptin.

Primary Outcome Measures

Name	Time	Method
development of type 2 diabetes mellitus by criteria of ADA 1997	3 years

Trial Locations

Locations (1)

Institut fuer Diabetesforschung; 🇩🇪 Munich, Germany