Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Adult; Diabetes Mellitus, Type 2

Treatments: Drug: Ertugliflozin 4 mg single dose; Drug: Ertugliflozin 2 mg split into twice daily; Drug: Ertugliflozin 4 mg split into twice daily; Drug: Placebo; Drug: Ertugliflozin 2 mg single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01054300

8835-040

B1521007 (Other Identifier)

MK-8835-040 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with type 2 diabetes mellitus, either treatment-naïve or on up to 2 acceptable oral anti-diabetes drugs for at least 8-weeks prior to study.

Exclusion criteria

• Participants with type 1 diabetes mellitus, participants with stroke, unstable angina, heart attack in last 6-months, uncontrolled blood pressure.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 4 patient groups

Cohort 1: Ertu 2 mg/Placebo (Pbo)→Ertu 1 mg/Ertu 1 mg

Experimental group

Description:

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.

Treatment:

Drug: Ertugliflozin 2 mg single dose

Drug: Placebo

Drug: Ertugliflozin 2 mg split into twice daily

Cohort 1: Ertu 1 mg/Ertu 1 mg→Ertu 2 mg/Pbo

Experimental group

Description:

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.

Treatment:

Drug: Ertugliflozin 2 mg single dose

Drug: Placebo

Drug: Ertugliflozin 2 mg split into twice daily

Cohort 2: Ertu 4 mg/Pbo→Ertu 2 mg/Ertu 2 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Ertugliflozin 4 mg single dose

Drug: Ertugliflozin 4 mg split into twice daily

Cohort 2: Ertu 2 mg/Ertu 2 mg→Ertu 4 mg/Pbo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Ertugliflozin 4 mg single dose

Drug: Ertugliflozin 4 mg split into twice daily