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

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 Drug: pioglitazone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Diabetes Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

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

Enrollment:	318
Study Start Date:	November 2004
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: vildagliptin 50 mg qd + pioglitazone 45 mg qd vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks	Drug: vildagliptin Drug: pioglitazone pioglitazone 45 mg qd
Experimental: vildagliptin 50 mg bd+ pioglitazone 45 mg qd vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks	Drug: vildagliptin Drug: pioglitazone pioglitazone 45 mg qd

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

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00138554 History of Changes
Other Study ID Numbers:	CLAF237A2304E1
Study First Received:	August 27, 2005
Last Updated:	May 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Vildagliptin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 13, 2013