Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Institut fur Diabetesforschung, Munich, Germany.
Recruitment status was:  Recruiting
Information provided by:
Institut fur Diabetesforschung, Munich, Germany Identifier:
First received: November 20, 2009
Last updated: June 24, 2011
Last verified: June 2011

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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

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 ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01018602

Contact: Anette G Ziegler, MD +49 (0)89 3068 2917 ext 2917

Institut fuer Diabetesforschung Recruiting
Munich, Germany, 80804
Contact: Anette G Ziegler, MD    +49 (0)89 3068 2917 ext 2917   
Principal Investigator: Anette G Ziegler, MD         
Sponsors and Collaborators
Institut fur Diabetesforschung, Munich, Germany
  More Information

Responsible Party: Prof. Dr. med. Anette-G. Ziegler, Institut fur Diabetesforschung, Munich, Germany Identifier: NCT01018602     History of Changes
Other Study ID Numbers: 808040006
Study First Received: November 20, 2009
Last Updated: June 24, 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 28, 2017