Conditions: Diabetes Mellitus, Type 2 Adult
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 52
Healthy volunteers: no

Brief summary:
This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning \[AM\] and evening \[PM\]) in adults with type 2 diabetes.

Detailed description:

Arms:
arm 1: Period 1: Ertu 2 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. There was a \>= 7 day washout period between Period 1 and Period 2. arm 2: Period 1: Ertu 1 mg in the AM and Ertu 1 mg in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Pbo in the PM for 1 day. There was a \>= 7 day washout period between Period 1 and Period 2. arm 3: Period 1: Ertu 4 mg in the AM and Pbo in the PM for 1 day. Period 2: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. There was a \>= 7 day washout period between Period 1 and Period 2. arm 4: Period 1: Ertu 2 mg in the AM and Ertu 2 mg in the PM for 1 day. Period 2: Ertu 4 mg in the AM and Pbo in the PM for 1 day. There was a \>= 7 day washout period between Period 1 and Period 2.

Interventions: intervention 1: Ertugliflozin 2 mg single dose intervention 2: Ertugliflozin 2 mg split into twice daily intervention 3: Ertugliflozin 4 mg single dose intervention 4: Ertugliflozin 4 mg split into twice daily intervention 5: Placebo
Intervention descriptions: intervention 1: Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose intervention 2: Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day intervention 3: Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose intervention 4: Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day intervention 5: Placebo to ertugliflozin administered as a single dose

Protocol document: