Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00237237

Purpose

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Metformin Metformin hydrochloride Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures:

Adverse event profile after 52 weeks of treatment
Change from baseline in fasting plasma glucose at 52 weeks
Change from baseline in body weight at 52 weeks
Patients with endpoint HbA1c < 7% after 52 weeks
Patients with reduction in HbA1c >/= to 7% after 52 weeks

Estimated Enrollment:	588
Study Start Date:	October 2005
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 77 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

On a stable dose of metformin as defined by the protocol
Blood glucose criteria must be met
Body mass index (BMI) in the range 22-45

Exclusion Criteria:

History of type 1 diabetes
Pregnancy or lactation
Evidence of significant diabetic complications
Serious cardiovascular events within the past 6 months
Laboratory value abnormalities as defined by the protocol
Known sensitivity to pioglitazone
Other protocol-defined exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237237

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany
Investigative Centers
Nurnberg, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Study ID Numbers:	CLAF237A2354
Study First Received:	October 9, 2005
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00237237
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin

Study placed in the following topic categories:

Metabolic Diseases
Pioglitazone
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Vildagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009