E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
previous gestational diabetes |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000137 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056997 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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< 18 kg/m2 or > 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |