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Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

NCT01059825 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2018-09-13

Study results available
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Summary

MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo to Ertugliflozin

Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days

DRUG

Ertugliflozin 1 mg

Tablet, 1 mg, once daily for 84 days

DRUG

Ertugliflozin 5 mg

Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days

DRUG

Ertugliflozin 25 mg

Tablet, 25 mg, once daily for 84 days

DRUG

Sitagliptin 100 mg

Tablet, 100 mg, once daily for 84 days

DRUG

Placebo to Sitagliptin

Tablet, matching placebo to 100 mg, once daily for 84 days

DRUG

Metformin

Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-24
Primary Completion
2011-01-20
Completion
2011-01-20
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 NCT01059825 on ClinicalTrials.gov