Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
- Conditions
- -E119 Non-insulin-dependent diabetes mellitus, without complicationsE119Non-insulin-dependent diabetes mellitus, without complications
- Registration Number
- PER-117-06
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1 - Men, women who are not fertile or have the potential to procreate who are using a medically approved method of birth control.
2- Age in the range of 18-78 years.
3- Patients with T2DM who have taken 850-1000 mg of daily dose of metformin as monotherapy for at least 2 months immediately before the visit 1.
4- Diagnosis of T2DM at least 2 months before entering the study (visit 1).
5- Body mass index (BMI) in the range of 22-45 kg / m2 at visit 1.
6- HbA1C in the range of 6.5-9.0% at visit 1.
7- FPG <270 mg / dL (15 mmol / L) at visit 1.
8- Written informed consent to participate in the study.
9- Ability to meet all the requirements of the study.
1. Pregnant or lactating woman.
2. History of: Type 1 diabetes, diabetes resulting from liver damage, or secondary forms of diabetes.
3. Evidence of significant diabetic complications.
4. Acute infections that may affect the control of blood glucose within 4 weeks prior to visit 1 and another concomitant medical condition that may interfere with the interpretation of efficacy and safety during the study.
5. Any of the following within the last 6 months: myocardial infarction (MI), coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or cerebrovascular accident.
6. Congestive heart failure (CHF) that requires pharmacological treatment.
7. Any of the following ECG abnormalities: Torsade 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.
8. Malignancy including leukemia and lymphoma during the past 5 years.
9. Liver disease such as cirrhosis or active chronic hepatitis.
10. Contraindications and warnings according to the country-specific label for metformin that are not found in the other exclusion criteria.
11. Chronic treatment with insulin within the last 6 months.
12. Treatment with other oral antidiabetic agents within 3 months prior to the visit 1.
13. Chronic oral or parenteral treatment within 8 weeks prior to visit 1.
14. Treatment with growth hormone or similar drugs.
15. Treatment with antiarrhythmics of classes la. Ib and lc or III.
16. Use of other investigational drugs on visit 1, or within 30 days or 5 half-lives for visit 1, whichever is longer.
17. Treatment with any drug with a known frequent toxicity to important organ systems within the last 3 months.
18. Any of the following significant laboratory abnormalities: ALT, AST greater than 3 times the upper limit at visit 1. Direct bilirubin greater than 1.3 times the upper limit at visit 1; clinically significant renal failure; clinically significant values of TSH at visit 1; clinically significant laboratory abnormalities, confirmed by repeated measurements in addition to hyperglycemia, hyperinsulinemia and glycosuria at visit 1; fasting triglycerides> 700 mg / dL at visit 1.
19. History of abuse of active substance within the last 2 years.
20. Participation in previous studies with vildagliptin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Values in peripheral blood of glycosylated hemoglobin (HbA1c). Where the baseline is defined as the HbA1c value obtained on the randomization day (Day 1, visit 2) or the measurement closest to day 1.<br><br>Measure:Change from baseline in HbA1c.<br>Timepoints:Week 24 or in the final visit.<br>
- Secondary Outcome Measures
Name Time Method