Overview

Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Gliclazide
Vildagliptin
Criteria
Inclusion Criteria:

- Not currently on drug therapy for type 2 diabetes

- Body mass index (BMI) in the range 22-45

- Blood glucose criteria must be met

Exclusion Criteria:

- Pregnancy or lactation

- Type 1 diabetes

- Evidence of significant diabetic complications

- Evidence of serious cardiovascular conditions

- Laboratory value abnormalities as defined by the protocol

- Other protocol-defined exclusion criteria may apply