A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ertugliflozin 5 mg; Ertugliflozin 10 mg; Placebo to Ertugliflozin; Metformin; Placebo to Metformin; Glimepiride
Intervention description: One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).; One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).; One placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).; 500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening for 2 weeks and 1000 mg (2 tablets 500 mg) in the morning and 1000 mg (2 tablets 500 mg) in the evening, thereafter.; 1 tablet in the morning and 1 tablet in the evening for 2 weeks, 2 tablets in the morning and 1 tablet in the evening for 2 weeks and 2 tablets in the morning and 2 tablets in the evening, thereafter.; Dosing and titration of glimepiride as rescue therapy was determined by the investigator.
Intervention MeSH terms: Metformin; Glimepiride; Ertugliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 461.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the
      treatment of participants with type 2 diabetes mellitus (T2DM) and inadequate glycemic
      control on diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a
      26-week placebo-controlled treatment period (Phase A), and a 26-week active treatment period
      (Phase B). The primary hypotheses of the trial are that at Week 26, the mean reduction from
      baseline in hemoglobin A1c (A1C) for 15 mg ertugliflozin is greater than that for placebo and
      the mean reduction from baseline in A1C for 5 mg ertugliflozin is greater than that for
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of T2DM in accordance to American Diabetes Association guidelines

          -  Participants with no prior allowable oral anti-hyperglycemic agents (AHA) for at least
             8 weeks prior to study participation or participants on a single allowable oral AHA at
             the start of study participation

          -  Participants on a single allowable AHA must be willing to discontinue this medication
             at the Screening Visit (S2) and remain off this medication for the duration of the
             trial. Allowable oral AHAs for discontinuation are metformin, sulfonylureas,
             dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides or alpha-glucosidase inhibitors.

        Exclusion Criteria:

          -  History of myocardial infarction, unstable angina, arterial revascularization, stroke,
             transient ischemic attack, or New York Heart Association (NYHA) functional class
             III-IV heart failure within 3 months of study participation

          -  A clinically significant electrocardiogram abnormality

          -  A history of malignancy ≤5 years prior to study participation, except for adequately
             treated basal or squamous cell skin cancer or in situ cervical cancer

          -  A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2)
             inhibitor or metformin

          -  On a blood pressure or lipid altering medication that have not been on a stable dose
             for at least 4 weeks prior to study participation

          -  A surgical procedure within 4 weeks prior to study participation or planned major
             surgery during the trial

          -  Donation of blood or blood products within 6 weeks of study participation or plans to
             donate blood or blood products at any time during the trial

          -  Pregnant or breast-feeding, or is expecting to conceive during the trial, including 14
             days following the last dose of study drug