Effects of the treatment with metformin and/or sitagliptin on β- cell function and insulin resistance in women with prior gestational diabetes.

INTERVENTION: 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 tablet Route of administration of the placebo: Oral use Trade Name: METFORAL*30CPR RIV 850MG Pharmaceutical Form: Coated tablet INN or Proposed INN: Metformin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 850‐ Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use CONDITION: previous gestational diabetes ; MedDRA version: 9.1 Level: LLT Classification code 10000137 ; MedDRA version: 9.1 Level: LLT Classification code 10056997 PRIMARY OUTCOME: 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). 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. Secondary Objective: 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