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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
• Interventions: Other: Placebo; Drug: Biphasic Remogliflozin Etabonate

• Registration Number: NCT02537470
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-01
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Placebo	Placebo
Arm 2	Biphasic Remogliflozin Etabonate	Biphasic remogliflozin etabonate

Primary Outcome Measures

Name	Time	Method
Glycosylated haemoglobin A1c (HbA1c) at Week 12	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (19)

Advanced Arizona Clinical Research; 🇺🇸 Tucson, Arizona, United States

Chase Medical Research; 🇺🇸 Waterbury, Connecticut, 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

Medical Research Unlimited; 🇺🇸 Hialeah, Florida, United States

Mountain View Clinical Research; 🇺🇸 Greer, South Carolina, United States

New Phase Research & Development; 🇺🇸 Knoxville, Tennessee, United States

Comprehensive Clinical Research; 🇺🇸 Berlin, New Jersey, United States

Juno Research, LLC; 🇺🇸 Houston, Texas, United States

Padre Coast Clinical Research; 🇺🇸 Corpus Christi, Texas, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Meridien Research; 🇺🇸 Tampa, Florida, United States

eStudySite, Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Albuquerque Clinical Trials, Inc; 🇺🇸 Albuquerque, New Mexico, United States

Austin Center for Clinical Research; 🇺🇸 Austin, Texas, United States

Wasatch Clinical Research; 🇺🇸 Salt Lake City, Utah, United States