NCT01054300

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Single Day Evaluation Of The Pharmacokinetic-Pharmacodynamic Effect Of Once And Twice Daily Oral Administration Of PF-04971729 In Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2
• Adult

Interventions

Type	Name	Description
DRUG	Ertugliflozin 2 mg single dose	Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose
DRUG	Ertugliflozin 2 mg split into twice daily	Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day
DRUG	Ertugliflozin 4 mg single dose	Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose
DRUG	Ertugliflozin 4 mg split into twice daily	Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day
DRUG	Placebo	Placebo to ertugliflozin administered as a single dose

Timeline

• Start date: 2010-02-17
• Primary completion: 2010-04-07
• Completion: 2010-04-07
• First posted: 2010-01-22
• Last updated: 2019-11-21
• Results posted: 2018-11-07

Regulatory

• FDA-regulated drug study