Overview

This trial is active, not recruiting.

Conditions type 2 diabetes mellitus, diabetes mellitus, type 2
Treatments biphasic remogliflozin etabonate, placebo
Phase phase 2
Sponsor BHV Pharma
Collaborator Integrium
Start date July 2015
End date July 2016
Trial size 180 participants
Trial identifier NCT02537470, BHV20200

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Other)
Placebo
placebo
Placebo Comparator
(Experimental)
Biphasic remogliflozin etabonate
biphasic remogliflozin etabonate
Experimental Drug

Primary Outcomes

Measure
Glycosylated haemoglobin A1c (HbA1c) at Week 12
time frame: 12 weeks

Secondary Outcomes

Measure
HbA1c
time frame: at weeks 4, 8 and 12
Fasting plasma glucose (FPG)
time frame: at Weeks 4, 8 and 12
Insulin
time frame: at Weeks 4, 8 and 12
C-peptide
time frame: at Weeks 4, 8 and 12
Total Cholesterol
time frame: at Weeks 4, 8 and 12
LDL-c
time frame: at Weeks 4, 8 and 12
HDL-c
time frame: at Weeks 4, 8 and 12
Serum Triglycerides
time frame: at Weeks 4, 8 and 12
Body Weight
time frame: at Weeks 4, 8 and 12
Waist Circumference
time frame: at Weeks 4, 8 and 12
Adverse Events (AE)
time frame: Over 12 weeks
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

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
Principal investigator Joel M Neutel, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by BHV Pharma.