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

Novartis Pharmaceuticals370 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

370

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin AMDRUG

vildagliptin pmDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Novartis Investigative Site

Investigative Centers, Germany

Outcomes

Primary Outcomes

Change from baseline in HbA1c at 24 weeks

Time frame: 24 weeks

Secondary Outcomes

Safety of vildagliptin in combination with metformin during 24 weeks of treatment

Time frame: 24 weeks

Change from baseline in fasting plasma glucose at 24 weeks

Time frame: 24 weeks

Patients with endpoint HbA1c < 7% after 24 weeks

Time frame: 24 weeks

Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks

Time frame: 24 weeks

Change from baseline in body weight at 24 weeks

Time frame: 24 weeks

Data from ClinicalTrials.gov

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