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).



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/13/2015
Start Date:December 2013
End Date:January 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study With a 78-Week Extension To Evaluate The Efficacy And Safety Of Ertugliflozin In Subjects With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy.

This is an efficacy and safety study of ertugliflozin in participants with type 2 diabetes
mellitus 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.

The trial includes a 13-15 week run-in period prior to randomization, and a 26-week,
double-blind, placebo-controlled treatment period (Phase A) followed by a 78-week
double-blind, extension period (Phase B).

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
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