Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 80
Updated:	1/20/2018
Start Date:	July 2015
End Date:	August 2016

A 12-week Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Determine the Efficacy and Safety of Biphasic Remogliflozin Etabonate When Administered to Subjects With Type 2 Diabetes Mellitus

This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of
doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered
over 12 weeks in subjects with type 2 diabetes mellitus.

Inclusion Criteria:

- Able to provide written informed consent

- Subject with clinical diagnosis of type 2 diabetes

- HbA1c 7.0 - 10.5% inclusive at Visit 1.

Exclusion Criteria:

- History of metabolic acidosis or ketoacidosis.

- Current active renal disease that is not related to hypertension or type 2 diabetes
(e.g. non-diabetic glomerulonephritis, interstitial nephritis, symptomatic
nephrolithiasis, etc.)

- Use of an investigational device or investigational drug within 30 days or 5
half-lives (whichever is longer) prior to Visit 1.

We found this trial at

sites

Chase Medical Research, LLC

500 Chase Parkway
Waterbury, Connecticut 06708

203-419-4420

Phone: 203-419-4407

from

Waterbury, CT