women with a recent history of gestational diabetes which required insulin therapy up to 7 months post-partum
Conditions
Interventions
Product Name: vildagliptin
Product Code: LAF237
Pharmaceutical Form: Tablet
Current Sponsor code: 808040006
Other descriptive name: Vildagliptin
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Forschergruppe Diabetes e. V. am Helmholtz Zentrum München
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of 24 month Vildagliptin treatment to reduce the progression to type 2 diabetes in islet autoantibody negative women with recent insulin treated GDM.;Secondary Objective: To determine the mechanism of action of Vildagliptin treatment by testing the hypothesis that Vildagliptin 100 mg qd improves beta cell function and insulin sensitivity. To determine the durability of clinical benefit of 24 month Vildagliptin 100 mg qd treatment. ;Primary end point(s): The primary end point will be diabetes diagnosed on the basis of a six-monthly oral glucose tolerance test according to the 1997 criteria of the American Diabetes Association: a value of plasma glucose above 140 mg/dl in the fasting state or 200 mg/dl two hours after a 75 g oral glucose load. Diagnosis will require confirmation by a second test within 6 weeks. If the diagnosis is not confirmed by the second test, the subject will continue treatment to the original random assignment. | — |
Countries
Germany
Outcome results
None listed