Last updated on December 2017

A Phase 3 clinical study of Ertugliflozin for patients with Type 2 Diabetes Mellitus with Stage 3 Chronic Kidney Disease who have inadequate glycemic control on metformin


Brief description of study

A Phase 3 clinical study of Ertugliflozin for patients with Type 2 Diabetes Mellitus with Stage 3 Chronic Kidney Disease who have inadequate glycemic control on metformin

Detailed Study Description

Purpose:
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.

Official Title:
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

Study Type: Interventional
Overall Recruitment Status: Recruiting
Study Start Date: December 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

Phase: III

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

Clinical Study Identifier: TX137579

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