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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537470
• Other study ID #: BHV20200
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2015
• Last updated: January 16, 2018
• Start date: July 2015
• Est. completion date: August 2016

Study information

• Verified date: January 2018
• Source: BHV Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Biphasic Remogliflozin Etabonate
Experimental Drug

Other:
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials, Inc	Albuquerque	New Mexico
United States	Austin Center for Clinical Research	Austin	Texas
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Padre Coast Clinical Research	Corpus Christi	Texas
United States	Mountain View Clinical Research	Greer	South Carolina
United States	Medical Research Unlimited	Hialeah	Florida
United States	Juno Research, LLC	Houston	Texas
United States	New Phase Research & Development	Knoxville	Tennessee
United States	eStudySite, Las Vegas	Las Vegas	Nevada
United States	Long Beach Center for Clinical Research	Long Beach	California
United States	Long Beach Clinical Trials	Long Beach	California
United States	National Research Institute	Los Angeles	California
United States	Progressive Medical Research	Port Orange	Florida
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Meridien Research	Tampa	Florida
United States	Advanced Arizona Clinical Research	Tucson	Arizona
United States	Orange County Research Center	Tustin	California
United States	Diablo Clinical Research	Walnut Creek	California
United States	Chase Medical Research	Waterbury	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
BHV Pharma	Integrium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated haemoglobin A1c (HbA1c) at Week 12		12 weeks
Secondary	HbA1c		at weeks 4, 8 and 12
Secondary	Fasting plasma glucose (FPG)		at Weeks 4, 8 and 12
Secondary	Insulin		at Weeks 4, 8 and 12
Secondary	C-peptide		at Weeks 4, 8 and 12
Secondary	Total Cholesterol		at Weeks 4, 8 and 12
Secondary	LDL-c		at Weeks 4, 8 and 12
Secondary	HDL-c		at Weeks 4, 8 and 12
Secondary	Serum Triglycerides		at Weeks 4, 8 and 12
Secondary	Body Weight		at Weeks 4, 8 and 12
Secondary	Waist Circumference		at Weeks 4, 8 and 12
Secondary	Adverse Events (AE)		Over 12 weeks
Secondary	Safety endpoints include AEs, incidence of urinary tract infections, incidence of genital fungal infections, vital signs, ECGs and standard laboratory tests		12 weeks