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.
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
19
sites
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500 Chase Parkway
Waterbury, Connecticut 06708
Waterbury, Connecticut 06708
203-419-4420
Phone: 203-419-4407
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