- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537470
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
Status
Completed
Intervention / Treatment
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
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Long Beach, California, United States, 90806
- Long Beach Clinical Trials
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Los Angeles, California, United States, 90057
- National Research Institute
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Tustin, California, United States, 92780
- Orange County Research Center
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Walnut Creek, California, United States, 94598
- Diablo Clinical Research
-
-
Connecticut
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Waterbury, Connecticut, United States, 06708
- Chase Medical Research
-
-
Florida
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Hialeah, Florida, United States, 33012
- Medical Research Unlimited
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Port Orange, Florida, United States, 32127
- Progressive Medical Research
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Tampa, Florida, United States, 33634
- Meridien Research
-
-
Nevada
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Las Vegas, Nevada, United States, 89109
- eStudySite, Las Vegas
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New Jersey
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Berlin, New Jersey, United States, 08009
- Comprehensive Clinical Research
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-
New Mexico
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Albuquerque, New Mexico, United States, 87102
- Albuquerque Clinical Trials, Inc
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South Carolina
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Greer, South Carolina, United States, 29651
- Mountain View Clinical Research
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Tennessee
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Knoxville, Tennessee, United States, 37909
- New Phase Research & Development
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Texas
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Austin, Texas, United States, 78756
- Austin Center for Clinical Research
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Corpus Christi, Texas, United States, 78404
- Padre Coast Clinical Research
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Houston, Texas, United States, 77074
- Juno Research, LLC
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Utah
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Salt Lake City, Utah, United States, 84107
- Wasatch Clinical Research
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-
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHV20200
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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