Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as Add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

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 designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone

Official title: A Multi-Center, Randomized, Open-Label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-Based Practice Setting.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in HemoglobinA1c (HbA1c) after 12 weeks of treatment

Secondary outcome:

Change from baseline in body weight after 12 weeks of treatment

Change from baseline in fasting plasma glucose (FPG) after 12 weeks of treatment

Incidence of prespecified adverse events while on treatment with study drug

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who have received a stable dose of metformin consisting of at least 1,000

mg/day for four weeks prior to Visit 1 (week-2)

- Agreement to maintain the same dose of metformin from screening to the end of the

study

- Age in the range of 18-80 years

- Body mass index (BMI) in the range of 22-40 kg/m2

- HbA1c in the range of 7. 0 to 10%

- FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria:

- A history of type 1 diabetes

- Liver disease

- Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks

prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Novartis patient recruitment website

Starting date: October 2006
Ending date: October 2007
Last updated: November 7, 2007