Conditions: Renal Insufficiency
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 39
Healthy volunteers: yes

Brief summary:
This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction, or severe kidney dysfunction. The safety and tolerability of Met DR was also examined. In addition, this study compared the behavior of a single dose of Met DR with that of extended-release metformin (Met XR) and placebo in subjects with the varying levels of kidney function described above.

Detailed description:

Arms:
arm 1: One dose of 1000 mg metformin delayed-release arm 2: One dose of 1000 mg metformin extended-release arm 3: One dose of Placebo

Interventions: intervention 1: Met DR intervention 2: Met XR intervention 3: Placebo
Intervention descriptions: intervention 1: metformin delayed-release tablets intervention 2: metformin extended-release tablets intervention 3: None

Protocol document: