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

BHV Pharma

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Treatments: Drug: Biphasic Remogliflozin Etabonate; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02537470

BHV20200

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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191 participants in 2 patient groups

Arm 1

Other group

Description:

Placebo

Treatment:

Other: Placebo

Arm 2

Experimental group

Description:

Biphasic remogliflozin etabonate

Treatment:

Drug: Biphasic Remogliflozin Etabonate