Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00616811

Purpose

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 24 weeks.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Sitagliptin phosphate Sitagliptin Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Active-Controlled Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment

Secondary Outcome Measures:

Relationship between renal function and concentration levels of vildagliptin and its metabolites after repeated doses of vildagliptin in patients with T2DM and severe renal insufficiency.
Efficacy of vildagliptin versus sitagliptin in patients with T2DM and severe renal insufficiency by assessing the hemoglobin A1c (HbA1c ) and fasting plasma glucose (FPG) reduction from baseline

Estimated Enrollment:	150
Study Start Date:	January 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both

Criteria

Inclusion criteria

History T2 DM
Severe Renal Impairment

Exclusion criteria

Glucose ≥ 270 mg/dL (≥15 mmol/L)
Patients undergoing any method of dialysis
Treatment with therapy other than sulfonylureas, TZDs ,insulin, and metiglinides

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616811

Contacts

Contact: Customer Information Center

(862) 778-8300

Locations

United States, Virginia
Medical College of Virginia	Recruiting
Richmond, Virginia, United States, 23298
Contact: Customer Information Center 862-778-8300

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CLAF237A23138
Study First Received:	February 4, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00616811
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Type 2 diabetes, vildagliptin

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Kidney Diseases
Metabolic disorder
Glucose Metabolism Disorders
Vildagliptin
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009