A Study To Evaluate The Efficacy And Safety Of Ertugliflozin In Participants With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy (MK-8835-007).
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ertugliflozin 5 mg; Ertugliflozin 15 mg; Placebo to Ertugliflozin; Glimepiride; Placebo to Glimepiride; Basal Insulin; Metformin
Intervention description: Ertugliflozin 5 mg orally (1 ertugliflozin 5 mg tablet and 1 placebo ertugliflozin 10 mg tablet), once daily from Day 1 to Week 104.; Ertugliflozin 15 mg orally (1 ertugliflozin 5 mg tablet and 1 ertugliflozin 10 mg tablet), once daily from Day 1 to Week 104.; Placebo to ertuglioflozin (1 placebo ertugliflozin 5 mg tablet and/or 1 placebo ertugliflozin 10 mg tablet), orally once daily from Day 1 to Week 104.; Open-label Glimepiride will be used for glycemic rescue therapy (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride) in the 26-week initial period. Blinded Glimepiride (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period.; Placebo to glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period. Dosing and titration of placebo to glimepiride is at the discretion of the investigator.; Basal insulin will be administered in the initial 26-week period for participants with glucose values exceeding protocol-specified values and for participants requiring rescue therapy in the 78-week extension period. Dosing and titration of basal insulin is at the discretion of the Investigator.; Metformin >=1500 mg/day, orally, once a day
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Glimepiride; Insulin Detemir; Ertugliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 621.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an efficacy and safety study of ertugliflozin in participants with type 2 diabetes
      mellitus (T2DM) and inadequate glycemic control on metformin monotherapy. The primary study
      hypothesis is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for
      ertugliflozin is greater than that for placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of T2DM in accordance to American Diabetes Association guidelines

          -  Participants must be receiving metformin monotherapy for less than 8 weeks prior to
             study participation or require change in their diabetes regimen to remain eligible to
             participate in the trial (including discontinuing anti-hyperglycemic agent [AHA]
             therapy) and must have a hemoglobin A1c of 7.0 to 10.5% (53-91 mmol/mol) after at
             least 8 weeks on a regimen of metformin monotherapy

        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 glimepiride

          -  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 6 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