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

Novartis Pharmaceuticals2,665 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,665

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

vildagliptin as add-on to metformin

thiazolidinedione (TZD)DRUG

TZD add-on to metformin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Change from baseline in HemoglobinA1c (HbA1c)

Time frame: after 12 weeks of treatment

Secondary Outcomes

Change from baseline in body weight

Time frame: after 12 weeks of treatment

Change from baseline in fasting plasma glucose (FPG)

Time frame: after 12 weeks of treatment

Incidence of prespecified adverse events while on treatment with study drug

Time frame: 12 week treatment duration

Data from ClinicalTrials.gov

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