Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A 28-week Extension to a 24-week Multicenter, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770081
• Other study ID #: CLAF237A23138E1
• Status: Completed
• Phase: Phase 3
• Start date: September 2008
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Complete the core study and consent for extension

Exclusion Criteria:

• Patient unable to comply with core study requirements

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency

Intervention

Drug:
• vildagliptin
50mg qd
• sitagliptin
25mg qd

Locations

Country	Name	City	State
United States	Aiken Center for Clinical Research	Aiken	South Carolina
United States	University of New Mexico Health Science Center	Albuquerque	New Mexico
United States	Lehigh Valley Hospital-Dept. of Medicine Research	Allentown	Pennsylvania
United States	Central Utah Clinic	American Fork	Utah
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Emory Clinic	Atlanta	Georgia
United States	Nephrology Associates of South Miami	Aventura	Florida
United States	AM Diabetes and Endocrinology Center	Bartlett	Tennessee
United States	Dolby Research, LLC	Baton Rouge	Louisiana
United States	Metabolic Center of Louisiana	Baton Rouge	Louisiana
United States	Harvard University (Joslin Diabetes Center)	Boston	Massachusetts
United States	Downstate University of Brooklyn	Brooklyn	New York
United States	Medical U of South Carolina	Charleston	South Carolina
United States	Diabetes and Endocrinology Specialist, Inc	Chesterfield	Missouri
United States	Hightop Medical Research Center	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	John Muir Clinical Research	Concord	California
United States	Bruce Samuels LLC	Covington	Louisiana
United States	Dallas Diabetes & Endocrine Center	Dallas	Texas
United States	North Texas Endocrine Center	Dallas	Texas
United States	Denver Nephrology PC	Denver	Colorado
United States	Iowa Diabetes & Endocrinology Research Center PLC	Des Moines	Iowa
United States	Medical Nephrology Associates	Dyersburg	Tennessee
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	Willamette Valley Clinical Studies	Eugene	Oregon
United States	Clinical Research and Consulting Center, LLC	Fairfax	Virginia
United States	Nephrology Associates of Northern Virginia	Fairfax	Virginia
United States	Meritcare Medical Group	Fargo	North Dakota
United States	Genesys Integrated Group Practice, PC	Flint	Michigan
United States	University of Florida Shands Hospital	Gainesville	Florida
United States	Joslin Diabetes Center at North Arundel Hospital	Glen Burnie	Maryland
United States	Hartford Hospital	Hartford	Connecticut
United States	Center for Diabetes & Endocrine Care	Hollywood	Florida
United States	Larry Levinson, D.O., PA	Hollywood	Florida
United States	University of Hawaii	Honolulu	Hawaii
United States	Baylor Clinic (BCM 621)	Houston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Phillips Medical Services, PLLC	Jackson	Mississippi
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Jefferson City Medical Group	Jefferson City	Missouri
United States	Arms, Dodge, Robinson, Wilber & Crouch, Inc.	Kansas City	Missouri
United States	Cray Diabetes Education Center	Kansas City	Kansas
United States	Platte Valley Medical Group	Kearney	Nebraska
United States	Western Nephrology & Metabolic Bone Disease PC	Lakewood	Colorado
United States	Mary K. Richards, MD. PA	Little Rock	Arkansas
United States	University of Arkanasas for Medical Sciences	Little Rock	Arkansas
United States	Academic Medical Research Institute	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	UW Health - West Clinic	Madison	Wisconsin
United States	Osler Medical Clinical Research	Melbourne	Florida
United States	Boise Kidney & Hypertension Institiute	Meridian	Idaho
United States	Crescent City Clinical Research Center	Metairie	Louisiana
United States	Egan Healthcare	Metairie	Louisiana
United States	University of South Alabama Medical Center	Mobile	Alabama
United States	Arthritis and Diabetes Clinic	Monroe	Louisiana
United States	UMDNJ-Robert Wood Johnson	New Brunswick	New Jersey
United States	Northern California Institute for Bone Health	Oakland	California
United States	Creighton Diabetes Center	Omaha	Nebraska
United States	Creighton Nephrology	Omaha	Nebraska
United States	SC Nephrology and Hyptertension Center, Inc.	Orangeburg	South Carolina
United States	HRRG	Orchard Park	New York
United States	Portland Hypertension and Nephrology	Oregon City	Oregon
United States	Dr. Wei Feng	Pasadena	California
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Anasazi Internal Medicine	Phoenix	Arizona
United States	Mississippi Medical Research, LLC	Picayune	Mississippi
United States	Renal Endocrine Associates, P. C.	Pittsburgh	Pennsylvania
United States	Medical College of Virginia	Richmond	Virginia
United States	Medical College of Virginia	Richmond	Virginia
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Biolab Research, LLC	Rockville	Maryland
United States	Sierra Clinical Research - Orangevale	Roseville	California
United States	Washington U School of Medicine	Saint Louis	Missouri
United States	Allied Institute of Medicine	San Antonio	Texas
United States	Renal Associates, P.A.	San Antonio	Texas
United States	California Institute of Renal Research	San Diego	California
United States	Sonoran Health Specialists	Scottsdale	Arizona
United States	Northwest Louisiana Nephrology Research	Shreveport	Louisiana
United States	Washington State University at Spokane	Spokane	Washington
United States	Sumter Medical Specialists	Sumter	South Carolina
United States	SUNY - Upstate Medical University	Syracuse	New York
United States	Tampa Bay Nephrology Associates	Tampa	Florida
United States	Cotton-O'Neil Diabetes & Endocrinology Center	Topeka	Kansas
United States	Western Nephrology & Metabolic Bone Disease PC	Westminster	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest)		52 weeks
Secondary	To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment		52 weeks

External Links

•   Results for CLAF237A23138E1 from the Novartis Clinical Trials website