Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Novartis

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: vildagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00494884

CLAF237ADE02

Details and patient eligibility

About

This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male, non-fertile female or female of childbearing potential using a medically approved birth control method
Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
Agreement to maintain the same dose of metformin throughout the study
Age in the range of 18-85 years inclusive.
HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1
Agreement to maintain prior diet and exercise habits during the full course of the study
Ability to comply with all study requirements and signed informed consent to participate in the study.

Exclusion criteria

Pregnant or lactating female

A history of:

type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.

Any of the following significant laboratory abnormalities:

ALT, AST greater than 2 times the upper limit of the normal range at visit 1.
Direct bilirubin greater than the upper limit of the normal range at visit 1.
Serum creatinine levels equal to or greater than 1.5 mg/dL (132 umol/L) males, equal to or greater than 1.4 mg/dL (123 umol/L) females, or a history of abnormal creatinine clearance at visit 1.
Clinically significant TSH values outside of normal range at visit 1.
Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

Other protocol-defined inclusion/exclusion criteria may apply