previous gestational diabetes MedDRA version: 9.1 Level: LLT Classification code 10000137 MedDRA version: 9.1 Level: LLT Classification code 10056997
Conditions
Interventions
Trade Name: JANUVIA
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tab
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women between 18 and 50; 2. caucasian race; 3. positive anamnesis for gestational diabet in the previous pregnancy, fulfilled for at least 1 year; 4. diagnosis of previous GDM defined according to Carpenter and Coustan criteria, i.e. FPG value = 126 mg/dl and/or two or more of the following condition after a 100-g oral glucose load in the oral glucose tolerance test (OGTT)0`? = 95 mg/dl, 60`? = 180 mg/dl, 120`? = 155 mg/dl, 180`? = 140 mg/dl;5. Use of an efficacious contraceptive method for at least 1 month and for all study duration; 6. written consent. 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. Previous diagnosis of DM type 1 and/or positivity of autoantibodies anti pancreatic insules (anti-GAD, anti-IA2); 2. diagnosis of DM in the 75-g OGTT, performed at entry, defined as a FPG value = 126 mg/dl and/or a PG value = 200 mg/dl 2 hours after the glucose load; 3. BMI 50 kg/m2; 4. chronic impaired renal function; 5. total hemoglobin rate < 12 g/dl 6. impaired liver function as shown by transaminase level = twice above the upper normal range; 7. breast-feeding women; 8. pregnant women, or women planning to become pregnant during the study, 9. history of hypersensitivity to metformin; 10. failure to use adequate contraception (women of current reproductive potential only); 11. mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study; 12. any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, heamatological or other major systemic disease or infective diseases making implementation of the protocol or interpretation of the study results difficult; 13. patient with underlying concomitant medication requiring a long-term use of drug potentially acting on glucose metabolism (e.g. corticosteroids, diuretics, or others); 14. hisory of drug or alcohol abuse within the last two years or current addiction to substances of abuse, 15. any disease or condition that in the opinion of investigator may interfere with the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confront the effect of the treatment with sitagliptin and metformin in association or in monotherapy on the beta-cellular function and on insulinic sensitivity in women with previous gestational diabetes (pGDM).;Secondary Objective: ;Primary end point(s): To value the effects of the treatment with sitagliptin and/or metformin, will be used as principal variable the beta-cellular function (ISR =Insulin Secretion Rate)calculated according to model proposed by Mari. | — |
Countries
Italy
Outcome results
None listed