A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin

Description

The purpose of this study is to compare the safety and effects (good and bad) of ertugliflozin compared with glimepiride on people with type 2 Diabetes Mellitus who are being treated with metformin with or without other diabetes medicines.

IRB Number: 014-057

Location: Wadley Tower, #656

Baylor Endocrine Center
3600 Gaston Ave.
Dallas, TX 75246

Details
Clinical Study IdentifierTX139168
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Subject has Type 2 DM (based on ADA/EASD guidelines [5])
Subject has a Visit 1/Screening A1C of ≥6.5% to ≤11.0%
Subject has either
(a) is currently on metformin and considered to have an indication for a second diabetes medication
(b) is currently on metformin along with a second diabetes medication other than insulin
Subject is ≥18 years of age on day of signing informed consent
Subject is a male, or a female who is highly unlikely to conceive as indicated by meeting at least one of the following criteria
Subject is not of reproductive potential
Subject is of reproductive potential and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study and for 14 days after the last dose of study medication

Exclusion Criteria

Subject has a history of Type 1 DM
Subject has a history of intolerance or hypersensitivity to SGLT2 inhibitor, glimepiride, and metformin
Has been treated with any of the following agents within 12 weeks of Visit 1/Screening or during the pre-randomization period
Insulin of any type (except for short-term [i.e., _7 days] use during hospitalization and no longer required)
Other injectable anti-hyperglycemic agents (AHA) [e.g., pramlintide exenatide, liraglutide]
Pioglitazone or rosiglitazone
Other SGLT2 inhibitor
Bromocriptine (Cycloset®)
Colesevelam (Welchol®)
Any other AHA with the exception of the protocol-approved agents
Subject is on a weight loss program and not in the maintenance phase, or has started a weight loss medication (such as orlistat, phentrimine, lorcaserin)
Subject is currently participating in, or has participated in a study with an investigational compound or device within the prior 12 weeks of signing informed consent or is not willing to refrain from participating in another study
Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
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