Overview

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

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Sitagliptin Phosphate
Vildagliptin
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