Trial | NCT02537470  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    191
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.
Study Started
Jul 31
2015
Primary Completion
Aug 31
2016
Study Completion
Aug 31
2016
Last Update
Jan 18
2018

Drug Biphasic Remogliflozin Etabonate

Experimental Drug

Other Placebo

Placebo Comparator

Arm 1 Other

Placebo

Arm 2 Experimental

Biphasic remogliflozin etabonate

Criteria 

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.
No Results Posted