Conditions: Renal Impairment Type 2 Diabetes Mellitus
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: yes

Brief summary:
This is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and in healthy participants with normal renal function.

Detailed description:

Arms:
arm 1: Ertugliflozin (15 mg), oral, administered in participants with T2DM and with normal renal function arm 2: Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment arm 3: Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment arm 4: Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment arm 5: Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function

Interventions: intervention 1: Ertugliflozin
Intervention descriptions: intervention 1: Single oral administration of 3 X 5 mg tablets.

Protocol document: