Type II Diabetes
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male, non-fertile female or female of childbearing potential using a medically approved birth control method. • A non-fertile female is defined as: post menopausal (12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m); 6 weeks post bilateral oophorectomy with or without hysterectomy; post hysterectomy; or sterilized by tubal ligation. • A female of childbearing potential is defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means. • Medically approved birth control method include: hormonal contraceptives, IUD, and double-barrier contraception. Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. • Reliable contraception should be maintained throughout the study. 2. Age in the range of 18 to 80 years inclusive. 3. Body mass index (BMI) in the range of 23-45 kg/m2 inclusive at visit 1. 4. Impaired glucose tolerances (IGT) as defined as: FPG =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female. 2. Diabetes, defined as any of the following: • FPG = 126mg/dL (7.0 mmol/L) at visit 1. • 2-hr post-challenge plasma glucose (after a 75-g OGTT) = 200 mg/dL (11.1 mmol/L) at visit 1. • Diabetes diagnosed by a physician and confirmed by other clinical data, other than gestational diabetes. • Use of insulin or any oral antidiabetic agents prior to visit 1, other than during pregnancy. 3. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1. 4. A history of: • Torsades de Pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation. • percutaneous coronary intervention within the past 3 months. • any of the following within the past 6 months: myocardial infarction (MI) (If the visit 2 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the subject can enter the study at the discretion of the investigator and the sponsor); coronary artery bypass surgery; unstable angina; or stroke. 5. Congestive heart failure NYHA class III or IV. 6. Any of the following ECG abnormalities: • second degree AV block (Mobitz 1 and 2) • third degree AV block • prolonged QTc (> 500 msec) 7. Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years. 8. Liver disease such as cirrhosis or chronic active hepatitis. 9. Significant renal dysfunction (see also exclusion criteria # 18 laboratory abnormalities). 10. Acromegaly or treatment with growth hormone or similar drugs. 11. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study. 12. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks. 13. Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1. 14. Treatment with class Ia, Ib and Ic or III anti-arrhythmics. 15. Thyroid hormone replacement is allowed if the dosage has been stable for at least 3 months. 16. Use of other investigational drugs at visit 1, or within 30 days or 5 half-lives of visit 1, whichever is longer, unless local health authority guidelines mandate a longer period. 17. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (i.e., cytostatic drugs). 18. Any of the following significant laboratory abnormalities: • ALT, AST greater than 3 times the upper limit of the normal range at visit 2. • Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 2. • Serum creatinine levels = 2.5 mg/dl (220 µmol/l) at visit 2. • Clinically significant TSH values outside normal range at visit 2. • Clinically significant laboratory abnormalities, confirmed by repeat measurement at visit 2. • Fasting triglycerides >700 mg/dl (>7.9 mmol/l) at visit 2. 19. History of active substance abuse (including alcohol) within the past 2 years. 20. Potentially unreliable subjects, and those judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of vildagliptin in subjects with IGT by testing the hypothesis that vildagliptin 50 mg qd reduces the area under the 0-2 hour prandial plasma glucose curve (AUC0-2hr) more than placebo following a standard meal challenge after 12 weeks of treatment.;Secondary Objective: 1. To demonstrate the safety of vildagliptin in subjects with IGT by showing that vildagliptin 50 mg qd has a similar adverse event profile to placebo after 12 weeks of treatment. 2. To demonstrate the efficacy of vildagliptin in subjects with IGT by testing the hypothesis that the ratio of the area under the 0-2 hour insulin secretion rate curve to the area under the 0-2 hour prandial plasma glucose curve with vildagliptin 50 mg qd is superior to that with placebo following a standard meal challenge after 12 weeks of treatment. 3. To demonstrate the mechanism of action of vildagliptin in subjects with IGT by testing the hypotheses that vildagliptin 50 mg qd improves ß-cell function relative to placebo after 12 weeks of treatment. For complete list see full protocol ;Primary end point(s): The primary efficacy variable is the change from baseline in the area under the prandial plasma glucose curve (AUC0-2hr) following a standard meal challenge at Week 12 or at the final visit with prandial plasma glucose AUC0-2hr for those subjects who do not have a Week 12 prandial plasma glucose AUC0-2hr measurement. | — |
Countries
Finland, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed