PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)
NCT ID: NCT01018602
Last Updated: 2011-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
140 participants
INTERVENTIONAL
2008-01-31
2015-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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vildagliptin
vildagliptin
100 mg per day over 24 months
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.
inactive pill
1 pill per day over 24 months
Interventions
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vildagliptin
100 mg per day over 24 months
inactive pill
1 pill per day over 24 months
Eligibility Criteria
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Inclusion Criteria
* \< 9 months after delivery
* age 18 years or older
* contraception during intervention period (at least 24 months)
Exclusion Criteria
* GADA or IA-2A positivity
* clinical overt diabetes
18 Years
FEMALE
Yes
Sponsors
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Institut fur Diabetesforschung, Munich, Germany
OTHER
Responsible Party
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Institut fur Diabetesforschung, Munich, Germany
Locations
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Institut fuer Diabetesforschung
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Hummel S, Beyerlein A, Pfirrmann M, Hofelich A, Much D, Hivner S, Bunk M, Herbst M, Peplow C, Walter M, Kohn D, Hummel N, Kratzsch J, Hummel M, Fuchtenbusch M, Hasford J, Ziegler AG; PINGUIN Study Group. Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study. Mol Metab. 2018 Mar;9:168-175. doi: 10.1016/j.molmet.2017.12.015. Epub 2018 Jan 3.
Other Identifiers
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808040006
Identifier Type: -
Identifier Source: org_study_id
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