MK-8835/PF-04971729 vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:2/8/2015
Start Date:December 2013
End Date:May 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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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

This study will evaluate the efficacy and safety of the addition of ertugliflozin
(MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM
who have inadequate glycemic control on metformin. The duration of the trial will be up to
approximately 122 weeks. This will include a 1-week screening period, an up to 13-week
wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week
double-blind, active comparator-controlled treatment period, and a post-treatment telephone
contact 14 days after the last dose of study drug. The primary hypothesis of this study is
that after 52 weeks, the change from baseline in hemoglobin A1C in participants treated with
the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in
participants treated with the addition of glimepiride.


Inclusion Criteria:

- Diagnosis of T2DM in accordance to American Diabetes Association guidelines

- On metformin monotherapy or metformin in combination with a single allowable
anti-hyperglycemic agent (AHA), dipeptidyl peptidase-4 (DPP-4) inhibitors,
meglitinides, or alpha-glucosidase inhibitors) prior to study participation.

- Body Mass Index (BMI) ≥18.0 kg/m^2

- Male or female not of reproductive potential

- If a female of reproductive potential, agree to remain abstinent or to use (or have
their partner use) 2 acceptable combinations of birth control while participating in
the trial and for 14 days after the last use of study drug.

Exclusion Criteria:

- History or presence of type 1 diabetes mellitus or a history of ketoacidosis

- History of other specific types of diabetes (eg, genetic syndromes, secondary
pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and
post-organ transplant).

- A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2
(SGLT2) inhibitor

- Use of the following prohibited therapeutic agents within 12 weeks of study
participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or
rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam
(Welchol®), and any other non-approved anti-hyperglycemic therapy

- Known hypersensitivity or intolerance to metformin or glimepiride

- On a weight-loss program or medication or medication associated with weight changes
and is not weight-stable (>=5% change in body weight in the last 6 months)

- History of bariatric surgery less than 12 months prior to study participation

- 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

- Active, obstructive uropathy or an indwelling urinary catheter

- 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

- Known history of Human Immunodeficiency Virus (HIV)

- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells

- A medical history of active liver disease (other than non-alcoholic hepatic
steatosis), including chronic active hepatitis B or C (assessed by medical history),
primary biliary cirrhosis, or symptomatic gallbladder disease

- Any clinically significant malabsorption condition

- Being treated for hyperthyroidism, or on thyroid replacement therapy that has not
been at a stable dose for at least 6 weeks prior to study participation

- Previous randomization in a study with ertugliflozin

- Participation in other studies involving investigational drug(s) within 30 days of
study participation and/or during the pre-randomization period

- A surgical procedure within 6 weeks prior to study participation or planned major
surgery during the trial

- A positive urine pregnancy test

- Pregnant or breast-feeding, or expecting to conceive during the trial, including 14
days following the last dose of study drug

- Undergoing hormonal therapy in preparation to donate eggs during the period of the
trial, including 14 days following the last dose of study drug

- Consumption of more than 2 alcoholic drinks per day or engages in binge drinking

- 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
We found this trial at
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