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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: vildagliptin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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 acarbose 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.

Official title: Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in HbA1c at 24 weeks

Secondary outcome:

Change from baseline in HbA1c at 24 weeks for subset of Chinese patients

Overall adverse event profile after 24 weeks of treatment

Gastrointestinal side effect profiles after 24 weeks of treatment

Change from baseline in fasting plasma glucose at 24 weeks

Patients with endpoint HbA1c <7% after 24 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Not currently on drug therapy for type 2 diabetes

- Body mass index (BMI) in the range 20-40

- 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.

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: April 2005
Last updated: January 2, 2007