Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes
Study Details
Study Description
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 the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Outcome Measures
Primary Outcome Measures
- Change from baseline in HbA1c at 24 weeks []
Secondary Outcome Measures
- Change from baseline in fasting plasma glucose at 24 weeks []
- Adverse event profile after 24 weeks of treatment []
- Patients with endpoint HbA1c <7% after 24 weeks []
- Patients with endpoint HbA1C <6.5% after 24 weeks []
- Patients with reduction in HbA1c >/= to 0.7% after 24 weeks []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Not previously treated with oral antidiabetic agents as defined by the protocol
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Blood glucose criteria must be met
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Body mass index (BMI) in the range 22-45
Exclusion Criteria:
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Pregnancy or lactation
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Type 1 diabetes
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Evidence of serious diabetic complications
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Evidence of serious cardiovascular complications
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Laboratory value abnormalities as defined by the protocol
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Known sensitivity to pioglitazone
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Other protocol-defined exclusion criteria may apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Novartis Pharmaceuticals | East Hanover | New Jersey | United States | 07936 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLAF237A2355