Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes
NCT ID: NCT02537470
Last Updated: 2018-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
191 participants
INTERVENTIONAL
2015-07-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Placebo
Placebo
Placebo Comparator
Arm 2
Biphasic remogliflozin etabonate
Biphasic Remogliflozin Etabonate
Experimental Drug
Interventions
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Biphasic Remogliflozin Etabonate
Experimental Drug
Placebo
Placebo Comparator
Eligibility Criteria
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Inclusion Criteria
* Subject with clinical diagnosis of type 2 diabetes
* HbA1c 7.0 - 10.5% inclusive at Visit 1.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Integrium
INDUSTRY
BHV Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Joel M Neutel, MD
Role: PRINCIPAL_INVESTIGATOR
Orange County Research Center
Locations
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Advanced Arizona Clinical Research
Tucson, Arizona, United States
Long Beach Clinical Trials
Long Beach, California, United States
Long Beach Center for Clinical Research
Long Beach, California, United States
National Research Institute
Los Angeles, California, United States
Orange County Research Center
Tustin, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Chase Medical Research
Waterbury, Connecticut, United States
Medical Research Unlimited
Hialeah, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Meridien Research
Tampa, Florida, United States
eStudySite, Las Vegas
Las Vegas, Nevada, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
Albuquerque Clinical Trials, Inc
Albuquerque, New Mexico, United States
Mountain View Clinical Research
Greer, South Carolina, United States
New Phase Research & Development
Knoxville, Tennessee, United States
Austin Center for Clinical Research
Austin, Texas, United States
Padre Coast Clinical Research
Corpus Christi, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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BHV20200
Identifier Type: -
Identifier Source: org_study_id
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