NCT00099892CompletedPhase 3
Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 544
- Locations
- 1
- Primary Endpoint
- Change from baseline in HbA1c after 24 weeks
Study Overview
Brief Summary
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 78 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Blood glucose criteria must be met
- •On a stable dose of metformin as defined by the protocol
- •Body mass index (BMI) in the range 22-45
Exclusion Criteria
- •Type 1 diabetes
- •Pregnancy or lactation
- •Evidence of serious diabetic complications
- •Evidence of serious cardiovascular complications
- •Laboratory value abnormalities as defined by the protocol
- •Other protocol-defined exclusion criteria may apply
Outcomes
Primary Outcomes
Change from baseline in HbA1c after 24 weeks
Secondary Outcomes
- Change from baseline in fasting plasma glucose at 24 weeks
- Patients with endpoint HbA1c <7% after 24 weeks
- Patients with reduction in HbA1c >/=to 0.7% after 24 weeks
- Change from baseline in body weight at 24 weeks
- Change from baseline in fasting lipids at 24 weeks
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00101803Novartis Pharmaceuticals527
Completed
Phase 3
Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00099944Novartis Pharmaceuticals515
Completed
Phase 3
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00099853Novartis Pharmaceuticals362
Completed
Phase 3
Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00099931Novartis Pharmaceuticals254
Completed
Phase 3
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT00106340Novartis Pharmaceuticals3,118