Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT01018602
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2009-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077597', 'term': 'Vildagliptin'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-24', 'studyFirstSubmitDate': '2009-11-20', 'studyFirstSubmitQcDate': '2009-11-20', 'lastUpdatePostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'development of type 2 diabetes mellitus by criteria of ADA 1997', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Insulin-dependent Gestational Diabetes']}, 'referencesModule': {'references': [{'pmid': '29396374', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nThe null hypothesis is that there is no significant difference of diabetes incidence (according to ADA criteria 1997) in both groups.\n\nPrimary 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with insulin-dependent gestational diabetes during the last pregnancy\n* \\< 9 months after delivery\n* age 18 years or older\n* contraception during intervention period (at least 24 months)\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* GADA or IA-2A positivity\n* clinical overt diabetes'}, 'identificationModule': {'nctId': 'NCT01018602', 'briefTitle': 'PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)', 'organization': {'class': 'OTHER', 'fullName': 'Institut fur Diabetesforschung, Munich, Germany'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '808040006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vildagliptin', 'interventionNames': ['Drug: vildagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'inactive pill without active agent', 'description': 'participants receive an inactive pill without active agent, but undergo the same examinations, visits and tests as the group treated with vildagliptin.', 'interventionNames': ['Drug: inactive pill']}], 'interventions': [{'name': 'vildagliptin', 'type': 'DRUG', 'description': '100 mg per day over 24 months', 'armGroupLabels': ['vildagliptin']}, {'name': 'inactive pill', 'type': 'DRUG', 'description': '1 pill per day over 24 months', 'armGroupLabels': ['inactive pill without active agent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80804', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Anette G Ziegler, MD', 'role': 'CONTACT', 'email': 'anziegler@lrz.uni-muenchen.de', 'phone': '+49 (0)89 3068 2917', 'phoneExt': '2917'}, {'name': 'Anette G Ziegler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut fuer Diabetesforschung', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Anette G Ziegler, MD', 'role': 'CONTACT', 'email': 'anziegler@lrz.uni-muenchen.de', 'phone': '+49 (0)89 3068 2917', 'phoneExt': '2917'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut fur Diabetesforschung, Munich, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. med. Anette-G. Ziegler', 'oldOrganization': 'Institut fur Diabetesforschung, Munich, Germany'}}}}