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

Sponsor
BHV Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02537470
Collaborator
Integrium (Industry)
191
Enrollment
19
Locations
2
Arms
13
Duration (Months)
10.1
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Biphasic Remogliflozin Etabonate
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
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 :
Jul 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Placebo

Other: Placebo
Placebo Comparator
Experimental: Arm 2

Biphasic remogliflozin etabonate

Drug: Biphasic Remogliflozin Etabonate
Experimental Drug

Outcome Measures

Primary Outcome Measures

  1. Glycosylated haemoglobin A1c (HbA1c) at Week 12 [12 weeks]

Secondary Outcome Measures

  1. HbA1c [at weeks 4, 8 and 12]

  2. Fasting plasma glucose (FPG) [at Weeks 4, 8 and 12]

  3. Insulin [at Weeks 4, 8 and 12]

  4. C-peptide [at Weeks 4, 8 and 12]

  5. Total Cholesterol [at Weeks 4, 8 and 12]

  6. LDL-c [at Weeks 4, 8 and 12]

  7. HDL-c [at Weeks 4, 8 and 12]

  8. Serum Triglycerides [at Weeks 4, 8 and 12]

  9. Body Weight [at Weeks 4, 8 and 12]

  10. Waist Circumference [at Weeks 4, 8 and 12]

  11. Adverse Events (AE) [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 [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Advanced Arizona Clinical Research Tucson Arizona United States 85712
2 Long Beach Clinical Trials Long Beach California United States 90806
3 Long Beach Center for Clinical Research Long Beach California United States 90807
4 National Research Institute Los Angeles California United States 90057
5 Orange County Research Center Tustin California United States 92780
6 Diablo Clinical Research Walnut Creek California United States 94598
7 Chase Medical Research Waterbury Connecticut United States 06708
8 Medical Research Unlimited Hialeah Florida United States 33012
9 Progressive Medical Research Port Orange Florida United States 32127
10 Meridien Research Tampa Florida United States 33634
11 eStudySite, Las Vegas Las Vegas Nevada United States 89109
12 Comprehensive Clinical Research Berlin New Jersey United States 08009
13 Albuquerque Clinical Trials, Inc Albuquerque New Mexico United States 87102
14 Mountain View Clinical Research Greer South Carolina United States 29651
15 New Phase Research & Development Knoxville Tennessee United States 37909
16 Austin Center for Clinical Research Austin Texas United States 78756
17 Padre Coast Clinical Research Corpus Christi Texas United States 78404
18 Juno Research, LLC Houston Texas United States 77074
19 Wasatch Clinical Research Salt Lake City Utah United States 84107

Sponsors and Collaborators

  • BHV Pharma
  • Integrium

Investigators

  • Principal Investigator: Joel M Neutel, MD, Orange County Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BHV Pharma
ClinicalTrials.gov Identifier:
NCT02537470
Other Study ID Numbers:
  • BHV20200
First Posted:
Sep 1, 2015
Last Update Posted:
Jan 18, 2018
Last Verified:
Jan 1, 2018
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Remogliflozin etabonate

Study Results

No Results Posted as of Jan 18, 2018