An Open-labeled, Randomized, Multicenter, Prospective, Parallel Group, Interventional Study to Demonstrate the Effectiveness of 24 Weeks Treatment With Vildagliptin 50mg Bid as Add on to Metformin 500 mg Bid Compared to Metformin up to 1000 mg Bid in Chinese Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy .
Overview
- Phase
- Phase 4
- Intervention
- Metformin
- Conditions
- Type 2 Diabetes
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 3091
- Locations
- 1
- Primary Endpoint
- Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chinese T2D patients who are inadequate controlled (6.5 %\< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks),
Exclusion Criteria
- •Type 1 diabetes and secondary diabetes
- •Acute metabolic diabetic complications within the past 3 months.
- •Acute infections which may influence glucose level.
- •Evidence of significant chronic diabetic complications,
- •Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis,
- •FPG \> 270 mg/dl (15 mmol/l)
- •Any of the following disease within the past 6 months: myocardial infarction (MI); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; Congestive heart failure (CHF)
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
metformin up titration
metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg)
Intervention: Metformin
vildagliptin add on to metformin
Vildagliptin 50 mg twice daily + Metformin 500mg twice daily
Intervention: Metformin
vildagliptin add on to metformin
Vildagliptin 50 mg twice daily + Metformin 500mg twice daily
Intervention: vildagliptin
Outcomes
Primary Outcomes
Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin
Time Frame: baseline, 24 weeks
The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks
Secondary Outcomes
- Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups(baseline and 24 weeks)
- Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%(baseline and 24 weeks)
- Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events(baseline and 24 weeks)
- Mean change from baseline in fasting plasma glucose (FPG)(baseline, 24 weeks)
- Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample(baseline, 24 weeks)
- Number of patients with adverse events, serious adverse events and death(up to 24 weeks)