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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02537470

Acronym

BRID

Enrollment

191

Registered

2015-09-01

Start date

2015-07-31

Completion date

2016-08-31

Last updated

2018-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus

Brief 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.

Interventions

DRUGBiphasic Remogliflozin Etabonate

Experimental Drug

OTHERPlacebo

Placebo Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Glycosylated haemoglobin A1c (HbA1c) at Week 12	12 weeks

Secondary

Measure	Time frame
Fasting plasma glucose (FPG)	at Weeks 4, 8 and 12
Insulin	at Weeks 4, 8 and 12
C-peptide	at Weeks 4, 8 and 12
Total Cholesterol	at Weeks 4, 8 and 12
LDL-c	at Weeks 4, 8 and 12
HbA1c	at weeks 4, 8 and 12
Serum Triglycerides	at Weeks 4, 8 and 12
Body Weight	at Weeks 4, 8 and 12
Waist Circumference	at Weeks 4, 8 and 12
Adverse Events (AE)	Over 12 weeks
Safety endpoints include AEs, incidence of urinary tract infections, incidence of genital fungal infections, vital signs, ECGs and standard laboratory tests	12 weeks
HDL-c	at Weeks 4, 8 and 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026