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

NCT ID: NCT02537470

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Placebo

Group Type OTHER

Placebo

Intervention Type OTHER

Placebo Comparator

Arm 2

Biphasic remogliflozin etabonate

Group Type EXPERIMENTAL

Biphasic Remogliflozin Etabonate

Intervention Type DRUG

Experimental Drug

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biphasic Remogliflozin Etabonate

Experimental Drug

Intervention Type DRUG

Placebo

Placebo Comparator

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Integrium

INDUSTRY

Sponsor Role collaborator

BHV Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joel M Neutel, MD

Role: PRINCIPAL_INVESTIGATOR

Orange County Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Advanced Arizona Clinical Research

Tucson, Arizona, United States

Site Status

Long Beach Clinical Trials

Long Beach, California, United States

Site Status

Long Beach Center for Clinical Research

Long Beach, California, United States

Site Status

National Research Institute

Los Angeles, California, United States

Site Status

Orange County Research Center

Tustin, California, United States

Site Status

Diablo Clinical Research

Walnut Creek, California, United States

Site Status

Chase Medical Research

Waterbury, Connecticut, United States

Site Status

Medical Research Unlimited

Hialeah, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Meridien Research

Tampa, Florida, United States

Site Status

eStudySite, Las Vegas

Las Vegas, Nevada, United States

Site Status

Comprehensive Clinical Research

Berlin, New Jersey, United States

Site Status

Albuquerque Clinical Trials, Inc

Albuquerque, New Mexico, United States

Site Status

Mountain View Clinical Research

Greer, South Carolina, United States

Site Status

New Phase Research & Development

Knoxville, Tennessee, United States

Site Status

Austin Center for Clinical Research

Austin, Texas, United States

Site Status

Padre Coast Clinical Research

Corpus Christi, Texas, United States

Site Status

Juno Research, LLC

Houston, Texas, United States

Site Status

Wasatch Clinical Research

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BHV20200

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.