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

NCT01018602 | Unknown Phase 2 DMC

• 1 other identifier: 808040006
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin-dependent Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• development of type 2 diabetes mellitus by criteria of ADA 1997

  3 years

Study Arms (2)

vildagliptin

ACTIVE COMPARATOR

Drug: vildagliptin

inactive pill without active agent

PLACEBO COMPARATOR

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

Interventions

vildagliptin DRUG

100 mg per day over 24 months

vildagliptin

inactive pill DRUG

1 pill per day over 24 months

inactive pill without active agent

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• pregnancy or lactation
• GADA or IA-2A positivity
• clinical overt diabetes

Sponsors & Collaborators

• Institut fur Diabetesforschung, Munich, Germany: lead

Study Sites (1)

Institut fuer Diabetesforschung

Munich, 80804, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 29396374 DERIVED

MeSH Terms

Interventions

Vildagliptin

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Anette G Ziegler, MD

CONTACT

+49 (0)89 3068 2917; anziegler@lrz.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 23, 2009
• Study Start: January 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2015
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

DE (1)