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

Institut fur Diabetesforschung, Munich, Germany

Status and phase: Unknown; Phase 2

Conditions: Insulin-dependent Gestational Diabetes

Treatments: Drug: vildagliptin; Drug: inactive pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01018602

808040006

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

vildagliptin

Active Comparator group

Treatment:

Drug: vildagliptin

inactive pill without active agent

Placebo Comparator group

Description:

participants receive an inactive pill without active agent, but undergo the same examinations, visits and tests as the group treated with vildagliptin.

Treatment:

Drug: inactive pill