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)



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/13/2015
Start Date:October 2013
End Date:August 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 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise

This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the
treatment of subjects 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 hypothesis of the trial is that at Week 26, the mean reduction from
baseline in hemoglobin A1c (HbA1c) for 15 mg ertugliflozin is greater than that for placebo.


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

- Particpants 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
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