Overview

Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Metformin
Vildagliptin
Criteria
Inclusion Criteria:

- Patients on metformin for at least three months and on a stable dose of at least 1500
mg daily for a minimum of 4 weeks prior to visit 1

- Body mass index in the range 22-40

- Blood glucose criteria must be met

Exclusion Criteria:

- Pregnancy or lactation

- History of type 1 diabetes

- Evidence of significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply