A multicenter, double-blind, randomized parallel-group study to demonstrate the effect of 24 weeks treatment with vildagliptin 100 mg qd as add-on to metformin 500 mg bid compared to metformin up to 1000 mg bid in patients with type 2 diabetes inadequately controlled on metformin 500 mg bid monotherapy - ND

Conditions: TYPE II DIABETES
MedDRA version: 8.1Level: LLTClassification code 10012601Term: Diabetes mellitus

Registration Number: EUCTR2006-003771-12-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 860

Inclusion Criteria

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 doublebarrier 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 18-78 years inclusive. 3- Patients with T2DM who have taken 850-1000 mg daily dose of metformin monotherapy for at least 2 months immediately prior to visit 1. 4- Diagnosis of T2DM for at least 2 months prior to study entry visit 1 . 5- Body mass index BMI in the range of 22-45 kg/m2 inclusive at visit 1. 6- HbA1c in the range of 6.5-9.0 inclusive at visit 1. 7- FPG 270 mg/dL 15 mmol/L at visit 1 measurement may be repeated once to confirm FPG value . 8- Written informed consent to participate in the study. 9- Ability to comply with all study requirements.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or lactating female. 2. A history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing s syndrome and acromegaly; acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state coma within the past 6 months. 3. Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy, gastroparesis, as well as symptoms of worsening hyperglycemia i.e. polyuria, polydipsia, weight loss in the absence of any intercurrent illness or other incidental circumstances potentially causing deterioration of glucose control. 4. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study. 5. Any of the following within the past 6 months myocardial infarction MI if the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor ; coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke. 6. Congestive heart failure CHF requiring pharmacological treatment. 7. 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 msec 8. Malignancy including leukemia and lymphoma not including basal cell skin cancer within the last 5 years. 9- Liver disease such as cirrhosis or chronic active hepatitis. 9. Contraindications and warnings according to the country specific label for metformin not listed in the other exclusion criteria. 10. Chronic insulin treatment 4 weeks of treatment in the absence of an intercurrent illness within the past 6 months. 11. Treatment with other oral antidiabetics within 3 months prior to visit 1. 12. Chronic oral or parenteral corticosteroid treatment 7 consecutive days of treatment within 8 weeks prior to visit 1. 13. Treatment with growth hormone or similar drugs. 14. Treatment with class Ia, Ib and Ic or III anti-arrhythmics. 15. 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. 16. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months i.e., cytostatic drugs . 17. Any of the following significant laboratory abnormalities ALT, AST greater than 3 times the upper limit of the normal range at visit 1; Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 1; Clinically significant renal dysfunction as indicated by serum creatinine levels 8805; 1.5 mg/d11- L 132 mol/L males, 8805; 1.4 mg/dL 123 mol/L females, or a history of abnormal creatinine clearance; Clinically significant TSH values outside of normal range at visit 1; Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1; Fasting triglycerides 700 mg/dL 7.9 mmol/L at visit 1. 18. History of active substance abuse including alcohol within the past 2 years. 19. Participation in previous vildagliptin studies.