Conditions: Diabetes Mellitus, Type 2 Chronic Renal Insufficiency
Keywords: Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).

Detailed description:

Arms:
arm 1: Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B. arm 2: Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.

Interventions: intervention 1: sitagliptin intervention 2: Placebo to Sitagliptin intervention 3: glipizide intervention 4: Placebo to glipizide
Intervention descriptions: intervention 1: One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily. intervention 2: One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min and not on dialysis) tablets of placebo to sitagliptin 25 mg daily. intervention 3: One 5 mg glipizide tablet per day. The dose of glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations. intervention 4: One placebo to glipizide 5 mg tablet per day. The dose of placebo to glipizide administered per day may be increased after 2 weeks and at 2-week intervals thereafter up to 20 mg based upon fingerstick glucose determinations.

Protocol document: