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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2, Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT00770081

Run by

Novartis

People needed

75

Starts

2008-09-01

Expected to finish

2011-04-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Complete the core study and consent for extension

You may not qualify if…

• Patient unable to comply with core study requirements

Where it is running

• Anasazi Internal Medicine — Phoenix, Arizona, United States
• Sonoran Health Specialists — Scottsdale, Arizona, United States
• Mary K. Richards, MD. PA — Little Rock, Arkansas, United States
• University of Arkanasas for Medical Sciences — Little Rock, Arkansas, United States
• Study site — Burlingame, California, United States
• John Muir Clinical Research — Concord, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Northern California Institute for Bone Health — Oakland, California, United States
• Dr. Wei Feng — Pasadena, California, United States
• Sierra Clinical Research - Orangevale — Roseville, California, United States
• California Institute of Renal Research — San Diego, California, United States
• Denver Nephrology PC — Denver, Colorado, United States
• Western Nephrology & Metabolic Bone Disease PC — Lakewood, Colorado, United States
• Western Nephrology & Metabolic Bone Disease PC — Westminster, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Nephrology Associates of South Miami — Aventura, Florida, United States
• University of Florida Shands Hospital — Gainesville, Florida, United States
• Center for Diabetes & Endocrine Care — Hollywood, Florida, United States
• Larry Levinson, D.O., PA — Hollywood, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Osler Medical Clinical Research — Melbourne, Florida, United States
• Tampa Bay Nephrology Associates — Tampa, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• University of South Alabama Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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