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

This study is currently recruiting participants.
Verified June 2011 by Institut fur Diabetesforschung, Munich, Germany
Sponsor:
Information provided by:
Institut fur Diabetesforschung, Munich, Germany
ClinicalTrials.gov Identifier:
NCT01018602
First received: November 20, 2009
Last updated: June 24, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Insulin-dependent Gestational Diabetes
 Drug: vildagliptin
Drug: inactive pill
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut fur Diabetesforschung, Munich, Germany:

Primary Outcome Measures:
  • development of type 2 diabetes mellitus by criteria of ADA 1997 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
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)
Arms Assigned Interventions
Active Comparator: vildagliptin Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018602

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

Locations
Germany
Institut fuer Diabetesforschung Recruiting
Munich, Germany, 80804
Contact: Anette G Ziegler, MD     +49 (0)89 3068 2917 ext 2917     anziegler@lrz.uni-muenchen.de    
Principal Investigator: Anette G Ziegler, MD            
Sponsors and Collaborators
Institut fur Diabetesforschung, Munich, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Anette-G. Ziegler, Institut fur Diabetesforschung, Munich, Germany
ClinicalTrials.gov Identifier: NCT01018602     History of Changes
Other Study ID Numbers: 808040006
Study First Received: November 20, 2009
Last Updated: June 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Vildagliptin
 Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013