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

Primary Purpose

Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Biphasic Remogliflozin Etabonate
Placebo
Sponsored by
BHV Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Advanced Arizona Clinical Research
  • Long Beach Clinical Trials
  • Long Beach Center for Clinical Research
  • National Research Institute
  • Orange County Research Center
  • Diablo Clinical Research
  • Chase Medical Research
  • Medical Research Unlimited
  • Progressive Medical Research
  • Meridien Research
  • eStudySite, Las Vegas
  • Comprehensive Clinical Research
  • Albuquerque Clinical Trials, Inc
  • Mountain View Clinical Research
  • New Phase Research & Development
  • Austin Center for Clinical Research
  • Padre Coast Clinical Research
  • Juno Research, LLC
  • Wasatch Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Placebo

Biphasic remogliflozin etabonate

Outcomes

Primary Outcome Measures

Glycosylated haemoglobin A1c (HbA1c) at Week 12

Secondary Outcome Measures

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

Full Information

First Posted
August 25, 2015
Last Updated
January 16, 2018
Sponsor
BHV Pharma
Collaborators
Integrium
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1. Study Identification

Unique Protocol Identification Number
NCT02537470
Brief Title
Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes
Acronym
BRID
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BHV Pharma
Collaborators
Integrium

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Placebo
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Biphasic remogliflozin etabonate
Intervention Type
Drug
Intervention Name(s)
Biphasic Remogliflozin Etabonate
Intervention Description
Experimental Drug
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Glycosylated haemoglobin A1c (HbA1c) at Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
at weeks 4, 8 and 12
Title
Fasting plasma glucose (FPG)
Time Frame
at Weeks 4, 8 and 12
Title
Insulin
Time Frame
at Weeks 4, 8 and 12
Title
C-peptide
Time Frame
at Weeks 4, 8 and 12
Title
Total Cholesterol
Time Frame
at Weeks 4, 8 and 12
Title
LDL-c
Time Frame
at Weeks 4, 8 and 12
Title
HDL-c
Time Frame
at Weeks 4, 8 and 12
Title
Serum Triglycerides
Time Frame
at Weeks 4, 8 and 12
Title
Body Weight
Time Frame
at Weeks 4, 8 and 12
Title
Waist Circumference
Time Frame
at Weeks 4, 8 and 12
Title
Adverse Events (AE)
Time Frame
Over 12 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel M Neutel, MD
Organizational Affiliation
Orange County Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Arizona Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Long Beach Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Long Beach Center for Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Chase Medical Research
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Medical Research Unlimited
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
eStudySite, Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Mountain View Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
New Phase Research & Development
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Austin Center for Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Padre Coast Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Juno Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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