Conditions: Diabetes Mellitus, Type 2 Renal Insufficiency, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 426
Healthy volunteers: no

Brief summary:
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.

Detailed description:

Arms:
arm 1: Sitagliptin + Placebo for Glipizide arm 2: Glipizide + Placebo for Sitagliptin

Interventions: intervention 1: Sitagliptin intervention 2: Glipizide intervention 3: Placebo for Sitagliptin intervention 4: Placebo for Glipizide
Intervention descriptions: intervention 1: Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily intervention 2: Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily) intervention 3: Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily intervention 4: Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily

Protocol document: