A double blind placebo controlled study to evaluate the effect ofbexagliflozin tablets on hemoglobin A1c in patients with type 2diabetes mellitus and moderate renal impairment

Theracos Sub, LLC0 sites300 target enrollmentAugust 11, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 11, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Theracos Sub, LLC

•1\. Men or non\-pregnant women \= 20 years of age. Women of childbearing potential must agree to use contraception during the entire study to avoid any possible pregnancy.
•Females who are surgically sterile (hysterectomy, oophorectomy) or postmenopausal (absence of menses greater than 12 months and age \> 45 years) are eligible if they test negative on the urine pregnancy test.
•2\. Subjects with a diagnosis of T2DM with an HbA1c between 7\.0 and 10\.5% (inclusive) at the time of screening.
•3\. Subjects who are treatment naïve or are treated with a stable regimen of anti\-diabetic medications. At the time of screening, the doses and frequency of all anti\-diabetic medications must have been stable for 8 weeks.
•4\. Subjects who have an estimated glomerular filtration rate (eGFR) \= 30 and
•\< 60 mL/min/1\.73 m2 at 2 time points: screening (V1\), and 1 additional time point between 1 and 12 monhs of screening (may be obtained from available medical records).
•The eGFR will be calculated by the MDRD equation.
•5\. Subjects who have a body mass index (BMI) \= 45 kg/m2 (inclusive)
•6\. Subjects who taking stable doses of medications for hypertension or hyperlipidemia for at least 30 days prior to randomization
•7\. Subjects who have stable eGFR between the historic value and day of screening (no more than 20% change in eGFR).

•1\. Diagnosis of type 1 diabetes mellitus or maturity–onset diabetes of the young (MODY)
•2\. Hemoglobinopathy that affects HbA1c measurement
•3\. Frequent symptomatic hypoglycemia (greater than one episode per week on average)
•4\. Genitourinary tract infection within 6 weeks of screening or history of \= 3 genitourinary infections requiring treatment within the last 6 months
•5\. Cancer, active or in remission for \< 3 years (Non\-melanoma skin cancer or basal cell carcinoma or carcinoma in situ of the cervix will not be grounds for exclusion)
•6\. History of alcohol or illicit drug abuse in the past 2 years
•7\. Evidence of abnormal liver function tests (total bilirubin or alkaline phosphatase \> 1\.5 x upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2\.5 x ULN
•8\. History of MI, stroke or hospitalization for heart failure, or hospitalization for unstable angina in the prior 3 months
•9\. Evidence of NYHA class IV heart failure at screening or randomization
•10\. Currently or within 3 months of taking an SGLT2 inhibitor from screening (Appendix 5\)