Postpartum Intervention in Women with Gestational Diabetes using Insulin - PINGUI

• Conditions: women with a recent history of gestational diabetes which required insulin therapy up to 7 months post-partum

• Registration Number: EUCTR2007-000634-39-DE
• Lead Sponsor: Forschergruppe Diabetes e. V. am Helmholtz Zentrum München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Female subjects who are at least 18 years of age, who are less than 7
months post-partum, and who had insulin treated GDM during their most
recent pregnancy (see 8)
2.Written informed consent to participate in the study
3.Ability to comply with all study requirements
4.Agree with the medication after finishing with breast feeding
5.Contraception after the last pregnancy for the next 2 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant or lactating female
2.GAD antibody or IA-2 antibody positive
3.Diabetes, defined as any of the following (FPG > 126mg/dL (7.0 mmol/L) at visit 1 or 2-hr post-challenge plasma glucose (after a 75-g OGTT) > 200 mg/dL (11.1 mmol/L) or diabetes diagnosed by a physician and confirmed by other clinical data, other than gestational diabetes
4.Use of insulin or any oral antidiabetic agents after pregnancy and prior to visit 1
5.concomitant use of drugs that affect carbohydrate metabolism
6.psychiatric disorders
7.history of vein thrombosis
8.bleeding disorders by clinical history
9.severe maternal or fetal complications during pregnancy
10.dietary only treatment during pregnancy
11.family planning within the next two years
12.Any of the following ECG abnormalities: Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree AV block (Mobitz 1 and 2), third degree AV block, prolonged QTc (> 500 ms)
13.malignancy including leukemia and lymphoma within the last 5 years
14.liver disease such as cirrhosis or chronic active hepatitis
15.treatment with growth hormone or similar drugs
16.chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1
17.treatment with class Ia, Ib and Ic or III anti-arrhythmics
18.any significant laboratory abnormalities at visit 1
19. Any of the following significant laboratory abnormalities
•ALT, AST > 2 times the upper limit of the normal range (ULN) at visit 1, confirmed by a repeat measure within 3 working days
•Total bilirubin > 2 times ULN and direct bilirubin > ULN at visit 1, confirmed by a repeat measure within 3 working days
20. Participation in another clinical trial within the last 3 months
21. Blood loss (e.g. by blood donation) of > 400 ml within the last 2 months
22. Any disease or condition which could impair study participation in the opinion of the
investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified