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Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)

NCT02226003 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2018-09-13

Study results available
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Summary

This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C (HbA1C) than placebo.

Conditions

Interventions

DRUG

Ertugliflozin

Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.

DRUG

Sitagliptin

Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.

DRUG

Placebo to Ertugliflozin

Matching placebo to ertugliflozin administered orally, once daily for 26 weeks.

DRUG

Placebo to Sitagliptin

Matching placebo to sitagliptin administered orally, once daily for 26 weeks.

DRUG

Glimepiride

Open-label glimepiride rescue therapy will be initiated at 1 or 2 mg/day and may be titrated to the maximum labeled dose or maximum tolerated dose (if lower than labeled dose), as considered appropriate by the investigator, based on blood glucose measurements and in accordance with the local, approved label.

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-23
Primary Completion
2016-02-23
Completion
2016-02-23

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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 NCT02226003 on ClinicalTrials.gov