A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001)



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:25 - Any
Updated:8/15/2015
Start Date:December 2013
End Date:September 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Background Antihyperglycemic Therapy

This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in
participants with type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who
have inadequate glycemic control on background antihyperglycemic therapy. The duration of
this trial will be up to 67 weeks. This will consist of a 1-week Screening Period, a
10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a
52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The
primary objective of this trial is to assess the 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 to the
addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of
ertugliflozin.


Inclusion Criteria:

- Diagnosis of T2DM

- On stable diabetes therapy (diet/exercise therapy alone or anti-hyperglycemic agents
[AHA] monotherapy or combination therapy) for at least 6 weeks prior to study
participation OR on metformin (with or without diet/exercise therapy or other AHA
therapy) and is willing to undergo a 10-week metformin wash-off period

- 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)

- History of nephrotic range proteinuria with hypoalbuminemia and edema

- History of rapidly progressive glomerulonephritis, lupus nephritis, renal or systemic
vasculitis, renal artery stenosis with renovascular hypertension, or ischemic
nephropathy

- History of familial renal glucosuria

- History of renal dialysis or renal transplant or renal disease requiring treatment
with any immunosuppressive agent

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

- Has been treated with rosiglitazone or other SGLT2 inhibitors 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 non-alcoholic 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 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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