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 Drug: Sitagliptin	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Vildagliptin Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

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 [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 24 weekd ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vildagliptin: Experimental	Drug: vildagliptin
Sitagliptin: Active Comparator	Drug: Sitagliptin

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Show 87 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CLAF237A23138
Study First Received:	February 4, 2008
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00616811 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:

Renal Insufficiency
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Vildagliptin
Protease Inhibitors
Sitagliptin

Dipeptidyl-Peptidase IV Inhibitors
Urologic Diseases
Diabetes Mellitus, Type 2
Kidney Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Renal Insufficiency
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Vildagliptin
Pharmacologic Actions

Sitagliptin
Protease Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Urologic Diseases
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009