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

January 16, 2018 updated by: BHV Pharma

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tucson, Arizona, United States, 85712
        • Advanced Arizona Clinical Research
    • California
      • Long Beach, California, United States, 90807
        • Long Beach Center For Clinical Research
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Tustin, California, United States, 92780
        • Orange County Research Center
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research
    • Florida
      • Hialeah, Florida, United States, 33012
        • Medical Research Unlimited
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Tampa, Florida, United States, 33634
        • Meridien Research
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • eStudySite, Las Vegas
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Mountain View Clinical Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • New Phase Research & Development
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Center for Clinical Research
      • Corpus Christi, Texas, United States, 78404
        • Padre Coast Clinical Research
      • Houston, Texas, United States, 77074
        • Juno Research, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Placebo
Placebo Comparator
Experimental: Arm 2
Biphasic remogliflozin etabonate
Experimental Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycosylated haemoglobin A1c (HbA1c) at Week 12
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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