Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00099853
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 362
Inclusion Criteria
- Blood glucose criteria must be met
- Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
- Body mass index (BMI) in the range 22-45
Exclusion Criteria
- Type 1 diabetes
- Pregnancy or lactation
- Evidence of serious cardiovascular complications
- Evidence of serious diabetic complications
- Laboratory value abnormalities as defined by the protocol
- Known sensitivity to pioglitazone
- Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vildagliptin placebo + pioglitazone 45 mg qd Placebo Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks Vildagliptin 50 mg bid + pioglitazone 45 mg qd Vildagliptin Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks Vildagliptin 50 mg qd + pioglitazone 45 mg qd Vildagliptin Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks Vildagliptin 50 mg qd + pioglitazone 45 mg qd pioglitazone Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks Vildagliptin 50 mg bid + pioglitazone 45 mg qd pioglitazone Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks Vildagliptin placebo + pioglitazone 45 mg qd pioglitazone Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c after 24 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in fasting plasma glucose at 24 weeks Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c Patients with endpoint HbA1c <7% after 24 weeks Patients with reduction in HbA1c >/= to 0.7% after 24 weeks Adverse event profile after 24 weeks of treatment
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States