Ignite Creation Date:
2024-05-05 @ 10:01 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01018602
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2009-11-20
Brief Title:
PINGUIN Postpartum Intervention in Women With Gestational Diabetes Using Insulin
Sponsor:
Institut fur Diabetesforschung Munich Germany
Organization:
Institut fur Diabetesforschung Munich Germany
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None