Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006)



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/16/2015
Start Date:March 2014
End Date:June 2016
Contact:Toll Free Toll Free Number
Phone:1-888-577-8839

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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin

This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment
of participants with type 2 diabetes mellitus who have inadequate glycemic control on
metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin
A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of
placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides
greater reduction in A1C compared with the addition of placebo; the primary objective will
be tested for both 5-mg and 15-mg doses of ertugliflozin.

The duration of the trial will be approximately 69 weeks. This will include a 1-week
Screening Period, an up to 12-week wash-off/titration /dose-stabilization period, a 2-week
single-blind, placebo run-in period, a 52-week double-blind, placebo-controlled treatment
period (including a 26-week Phase A and 26-week Phase B), and a post-treatment telephone
contact 14 days after the last dose of blinded investigational product.

Inclusion Criteria:

- Diagnosis of type 2 diabetes mellitus (T2DM)

- On stable diabetes therapy of metformin with either sitagliptin or another dipeptidyl
peptidase-4 (DPP-4) inhibitor or a sulfonylurea (SU) prior to study participation and
is willing to wash-off/switch from another DPP-4 inhibitor/SU to sitagliptin

- Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2

- Male, postmenopausal female or surgically sterile female

- If a female of reproductive potential, agrees 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 of type 1 diabetes mellitus or a history of ketoacidosis

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

- A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2
(SGLT2) or DPP-4 inhibitor

- On a weight-loss program or weight-loss medication or other medication associated
with weight changes and is not weight stable

- Has undergone bariatric surgery within the past 12 months or >12 months and is not
weight stable

- Has been treated with insulin (except for short-term use [<= 7 days]), injectable
antihyperglycemic agents (AHAs) (e.g., pramlintide, exenatide, liraglutide),
pioglitazone or rosiglitazone, other sodium-glucose co-transporter 2 (SGLT2)
inhibitors, alpha glucosidase inhibitors or meglitinides, bromocriptine (Cycloset™),
colesevelam (Welchol™), or any other nonapproved AHAs within 12 weeks of study
participation

- Has active, obstructive uropathy or indwelling urinary catheter

- 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 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)

- Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
or any other clinically significant hematological disorder (such as aplastic anemia,
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

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

- Has any clinically significant malabsorption condition

- If taking thyroid replacement therapy, has not been on a stable dose for at least 6
weeks prior to study participation

- Has been previously randomized in a study with ertugliflozin

- Has participated in other studies involving an investigational drug within 30 days
prior or during study participation

- Has undergone a surgical procedure within 6 weeks prior to or planned major surgery
during study participation

- Has a positive urine pregnancy test

- Is pregnant or breast-feeding, or is planning to conceive during the trial, including
14 days following the last dose of study medication

- Planning to undergo hormonal therapy in preparation to donate eggs during the trial,
including 14 days following the last dose of study medication

- Excessive consumption of alcoholic beverages or binge drinking

- Has donated blood or blood products within 6 weeks of study participation or plans to
donate blood or blood products at any time during the trial
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