Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

This study has been completed.

First Received: August 27, 2005 Last Updated: August 3, 2006 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00138554

Purpose

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety of vildagliptin in combination with pioglitazone during 52 weeks of treatment
Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures:

Change in HbA1c between 24 weeks and 52 weeks
Change from baseline in fasting plasma glucose at 52 weeks
Change in fasting plasma glucose between 24 weeks and 52 weeks
Change from baseline in HOMA B at 52 weeks
Change from baseline in HOMA IR at 52 weeks

Estimated Enrollment:	345
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Only patients successfully completing study CLAF237A2304 are eligible
Written informed consent
Ability to comply with all study requirements

Exclusion Criteria:

Premature discontinuation from study CLAF237A2304
Other protocol-defined exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138554

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CLAF237A2304E1
Study First Received:	August 27, 2005
Last Updated:	August 3, 2006
ClinicalTrials.gov Identifier:	NCT00138554 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin

Study placed in the following topic categories:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Vildagliptin
Metabolic Disorder
Protease Inhibitors

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Pioglitazone
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 May 07, 2009