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Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

NCT01999218 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1326

Last updated 2019-04-02

Study results available
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Summary

This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.

Conditions

Interventions

DRUG

Ertugliflozin 5 mg

Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104

DRUG

Ertugliflozin 10 mg

Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.

DRUG

Glimerpiride

Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose

DRUG

Placebo to Ertugliflozin

Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104

DRUG

Placebo to Glimepiride

Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.

DRUG

Metformin

Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \<1500 at screening are up-titrated to \>= 1500 daily.

DRUG

Sitagliptin

Open label, oral, once daily, rescue medication as required.

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
2013-12-16
Primary Completion
2017-04-18
Completion
2017-04-18

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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 NCT01999218 on ClinicalTrials.gov