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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

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 24 weeks.

Key facts

Study ID

NCT00616811

Run by

Novartis

People needed

148

Starts

2008-01-01

Expected to finish

2010-10-01

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…

• History T2 DM
• Severe Renal Impairment

You may not qualify if…

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

Where it is running

• Anasazi Internal Medicine — Phoenix, Arizona, United States
• University of Arkanasas for Medical Sciences — Little Rock, Arkansas, United States
• Office of William Zigrang — 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
• 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
• 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
• Emory Clinic — Atlanta, Georgia, United States
• University of Hawaii — Honolulu, Hawaii, United States
• Boise Kidney & Hypertension Institiute — Meridian, Idaho, United States
• Iowa Diabetes & Endocrinology Research Center PLC — Des Moines, Iowa, United States
• University of South Alabama Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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