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. The purpose of this study is 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 either pioglitazone or rosiglitazone alone.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin Drug: pioglitazone Drug: Placebo	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:	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:

Change from baseline in HbA1c after 24 weeks

Secondary Outcome Measures:

Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c >/= to 0.7% after 24 weeks
Adverse event profile after 24 weeks of treatment
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c

Enrollment:	362
Study Start Date:	May 2004
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (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 24 weeks	Drug: Vildagliptin Vildagliptin 50 mg tablets Other Names: LAF237 Galvus Drug: pioglitazone pioglitazone 45 mg qd
Experimental: Vildagliptin 50 mg bid + pioglitazone 45 mg qd Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks	Drug: Vildagliptin Vildagliptin 50 mg tablets Other Names: LAF237 Galvus Drug: pioglitazone pioglitazone 45 mg qd
Placebo Comparator: Vildagliptin placebo + pioglitazone 45 mg qd Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks	Drug: pioglitazone pioglitazone 45 mg qd Drug: Placebo Vildagliptin matching placebo

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Blood glucose criteria must be met
Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
Body mass index (BMI) in the range 22-45

Exclusion Criteria:

Type 1 diabetes
Pregnancy or lactation
Evidence of serious cardiovascular complications
Evidence of serious diabetic complications
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: NCT00099853

Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007 Mar;9(2):166-74.

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00099853 History of Changes
Other Study ID Numbers:	CLAF237A2304
Study First Received:	December 21, 2004
Last Updated:	January 2, 2013
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