PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)
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|ClinicalTrials.gov Identifier: NCT01018602|
Recruitment Status : Unknown
Verified June 2011 by Institut fur Diabetesforschung, Munich, Germany.
Recruitment status was: Recruiting
First Posted : November 23, 2009
Last Update Posted : June 27, 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 or disease||Intervention/treatment||Phase|
|Insulin-dependent Gestational Diabetes||Drug: vildagliptin Drug: inactive pill||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2015|
|Active Comparator: 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
- development of type 2 diabetes mellitus by criteria of ADA 1997 [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018602
|Contact: Anette G Ziegler, MD||+49 (0)89 3068 2917 ext firstname.lastname@example.org|
|Institut fuer Diabetesforschung||Recruiting|
|Munich, Germany, 80804|
|Contact: Anette G Ziegler, MD +49 (0)89 3068 2917 ext 2917 email@example.com|
|Principal Investigator: Anette G Ziegler, MD|