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

NCT01054300 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-11-21

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-17
Primary Completion
2010-04-07
Completion
2010-04-07
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054300 on ClinicalTrials.gov