Clinical trial NCT02537470: Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Lead sponsor: BHV Pharma
Sponsor class: INDUSTRY
Collaborators: name: Integrium
First posted: 2015-09-01
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Glycosylated haemoglobin A1c (HbA1c) at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: at weeks 4, 8 and 12
measure: Fasting plasma glucose (FPG)
timeFrame: at Weeks 4, 8 and 12
measure: Insulin
timeFrame: at Weeks 4, 8 and 12
measure: C-peptide
timeFrame: at Weeks 4, 8 and 12
measure: Total Cholesterol
timeFrame: at Weeks 4, 8 and 12
measure: LDL-c
timeFrame: at Weeks 4, 8 and 12
measure: HDL-c
timeFrame: at Weeks 4, 8 and 12
measure: Serum Triglycerides
timeFrame: at Weeks 4, 8 and 12
measure: Body Weight
timeFrame: at Weeks 4, 8 and 12
measure: Waist Circumference
timeFrame: at Weeks 4, 8 and 12
measure: Adverse Events (AE)
timeFrame: Over 12 weeks
measure: Safety endpoints include AEs, incidence of urinary tract infections, incidence of genital fungal infections, vital signs, ECGs and standard laboratory tests
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Advanced Arizona Clinical Research
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Clinical Trials
state: California
city: Long Beach
country: United States
facility: Long Beach Center for Clinical Research
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Waterbury
country: United States
facility: Chase Medical Research
state: Connecticut
city: Hialeah
country: United States
facility: Medical Research Unlimited
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Las Vegas
country: United States
facility: eStudySite, Las Vegas
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc
state: New Mexico
city: Greer
country: United States
facility: Mountain View Clinical Research
state: South Carolina
city: Knoxville
country: United States
facility: New Phase Research & Development
state: Tennessee
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Corpus Christi
country: United States
facility: Padre Coast Clinical Research
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
Study officials:
affiliation: Orange County Research Center
name: Joel M Neutel, MD
role: PRINCIPAL_INVESTIGATOR
References: