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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BHV Pharma
• Collaborator: Integrium
• Treatments: 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.