Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone

This study has been completed.

First Received: November 2, 2006 Last Updated: July 13, 2009 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00396357

Purpose

This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment

Secondary Outcome Measures:

Adverse event profile after 24 weeks of treatment
Gastrointestinal tolerability after 24 weeks of treatment
Patients with endpoint HbA1c <7% and <6.5% after 24 weeks
Patients with reduction in HbA1c >0.7% after 24 weeks
Change from baseline in fasting plasma glucose after 24 weeks

Estimated Enrollment:	860
Study Start Date:	October 2006
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

18-78 years inclusive
Type 2 diabetes diagnosis at least 2 months prior to study entry
Body mass index in the range of 22-45 kg/m2
HbA1c in the range of 6.5 to 9% inclusive
Fasting plasma glucose <270 mg/dL (15 mmol/L)

Exclusion Criteria:

A history of type 1 diabetes
Evidence of significant diabetic complications
Treatment with insulin or any other oral antidiabetic agents
Congestive heart failure requiring pharmacologic treatment
Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396357

Locations

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

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CLAF237A23104
Study First Received:	November 2, 2006
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00396357 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin
hemoglobin A1c
metformin

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Vildagliptin
Pharmacologic Actions
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010