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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537470
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Integrium
Information provided by (Responsible Party):
BHV Pharma

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Drug: Biphasic Remogliflozin Etabonate Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Arm 1
Placebo
Other: Placebo
Placebo Comparator

Experimental: Arm 2
Biphasic remogliflozin etabonate
Drug: Biphasic Remogliflozin Etabonate
Experimental Drug




Primary Outcome Measures :
  1. Glycosylated haemoglobin A1c (HbA1c) at Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: at weeks 4, 8 and 12 ]
  2. Fasting plasma glucose (FPG) [ Time Frame: at Weeks 4, 8 and 12 ]
  3. Insulin [ Time Frame: at Weeks 4, 8 and 12 ]
  4. C-peptide [ Time Frame: at Weeks 4, 8 and 12 ]
  5. Total Cholesterol [ Time Frame: at Weeks 4, 8 and 12 ]
  6. LDL-c [ Time Frame: at Weeks 4, 8 and 12 ]
  7. HDL-c [ Time Frame: at Weeks 4, 8 and 12 ]
  8. Serum Triglycerides [ Time Frame: at Weeks 4, 8 and 12 ]
  9. Body Weight [ Time Frame: at Weeks 4, 8 and 12 ]
  10. Waist Circumference [ Time Frame: at Weeks 4, 8 and 12 ]
  11. Adverse Events (AE) [ Time Frame: Over 12 weeks ]
  12. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537470


Locations
Show Show 19 study locations
Sponsors and Collaborators
BHV Pharma
Integrium
Investigators
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Principal Investigator: Joel M Neutel, MD Orange County Research Center
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Responsible Party: BHV Pharma
ClinicalTrials.gov Identifier: NCT02537470    
Other Study ID Numbers: BHV20200
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Remogliflozin etabonate
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs