Clinical trial NCT00616811: Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes, vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 24 weeks.


Eligibility 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

Primary outcomes:
measure: Safety and tolerability in patients with T2DM and severe renal insufficiency over 24 weeks of treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: 24 weekd
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Anasazi Internal Medicine
state: Arizona
city: Little Rock
country: United States
facility: University of Arkanasas for Medical Sciences
state: Arkansas
city: Burlingame
country: United States
facility: Office of William Zigrang
state: California
city: Concord
country: United States
facility: John Muir Clinical Research
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Oakland
country: United States
facility: Northern California Institute for Bone Health
state: California
city: Pasadena
country: United States
facility: Dr. Wei Feng
state: California
city: Roseville
country: United States
facility: Sierra Clinical Research - Orangevale
state: California
city: Denver
country: United States
facility: Denver Nephrology PC
state: Colorado
city: Lakewood
country: United States
facility: Western Nephrology & Metabolic Bone Disease PC
state: Colorado
city: Westminster
country: United States
facility: Western Nephrology & Metabolic Bone Disease PC
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Aventura
country: United States
facility: Nephrology Associates of South Miami
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Hollywood
country: United States
facility: Center for Diabetes & Endocrine Care
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Melbourne
country: United States
facility: Osler Medical Clinical Research
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Nephrology Associates
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
city: Meridian
country: United States
facility: Boise Kidney & Hypertension Institiute
state: Idaho
city: Des Moines
country: United States
facility: Iowa Diabetes & Endocrinology Research Center PLC
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: Cray Diabetes Education Center
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Diabetes & Endocrinology Center
state: Kansas
city: Baton Rouge
country: United States
facility: Dolby Research, LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: Metabolic Center of Louisiana
state: Louisiana
city: Covington
country: United States
facility: Bruce Samuels LLC
state: Louisiana
city: Metairie
country: United States
facility: Crescent City Clinical Research Center
state: Louisiana
city: Metairie
country: United States
facility: Egan Healthcare
state: Louisiana
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic
state: Louisiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology Research
state: Louisiana
city: Glen Burnie
country: United States
facility: Joslin Diabetes Center at North Arundel Hospital
state: Maryland
city: Rockville
country: United States
facility: Biolab Research, LLC
state: Maryland
city: Flint
country: United States
facility: Genesys Integrated Group Practice, PC
state: Michigan
city: Jackson
country: United States
facility: Phillips Medical Services, PLLC
state: Mississippi
city: Picayune
country: United States
facility: Mississippi Medical Research, LLC
state: Mississippi
city: Chesterfield
country: United States
facility: Diabetes and Endocrinology Specialist, Inc
state: Missouri
city: Jefferson City
country: United States
facility: Jefferson City Medical Group
state: Missouri
city: Kansas City
country: United States
facility: Arms, Dodge, Robinson, Wilber & Crouch, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Washington U School of Medicine
state: Missouri
city: Kearney
country: United States
facility: Platte Valley Medical Group
state: Nebraska
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Omaha
country: United States
facility: Creighton Nephrology
state: Nebraska
city: New Brunswick
country: United States
facility: UMDNJ-Robert Wood Johnson
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
city: Brooklyn
country: United States
facility: Downstate University of Brooklyn
state: New York
city: Orchard Park
country: United States
facility: HRRG
state: New York
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: New York
city: Syracuse
country: United States
facility: SUNY - Upstate Medical University
state: New York
city: Fargo
country: United States
facility: Meritcare Medical Group
state: North Dakota
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital-Dept. of Medicine Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Renal Endocrine Associates, P. C.
state: Pennsylvania
city: Aiken
country: United States
facility: Aiken Center for Clinical Research
state: South Carolina
city: Charleston
country: United States
facility: Medical U of South Carolina
state: South Carolina
city: Orangeburg
country: United States
facility: SC Nephrology and Hyptertension Center, Inc.
state: South Carolina
city: Sumter
country: United States
facility: Sumter Medical Specialists
state: South Carolina
city: Bartlett
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: Dyersburg
country: United States
facility: Medical Nephrology Associates
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes & Endocrine Center
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences
state: Texas
city: Houston
country: United States
facility: Baylor Clinic (BCM 621)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Allied Institute of Medicine
state: Texas
city: American Fork
country: United States
facility: Central Utah Clinic
state: Utah
city: Fairfax
country: United States
facility: Clinical Research and Consulting Center, LLC
state: Virginia
city: Richmond
country: United States
facility: Medical College of Virginia
state: Virginia
city: Richmond
country: United States
facility: Medical College of Virginia
state: Virginia
city: Spokane
country: United States
facility: Washington State University at Spokane
state: Washington
city: Madison
country: United States
facility: UW Health - West
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals Corporation
role: STUDY_DIRECTOR
References:
citation: Kothny W, Lukashevich V, Foley JE, Rendell MS, Schweizer A. Comparison of vildagliptin and sitagliptin in patients with type 2 diabetes and severe renal impairment: a randomised clinical trial. Diabetologia. 2015 Sep;58(9):2020-6. doi: 10.1007/s00125-015-3655-z. Epub 2015 Jun 12.