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Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes | Clinical Trials | Clareo Health

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

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

NCT02537470•BHV Pharma

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (19)

Advanced Arizona Clinical Research

Tucson, Arizona, 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

Chase Medical Research

Waterbury, Connecticut, United States

Medical Research Unlimited

Hialeah, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Meridien Research

Tampa, Florida, United States

Key Dates

Start Date

July 1, 2015

Primary Completion Date

August 1, 2016

Completion Date

August 1, 2016

Last Updated

January 18, 2018

Enrollment

191

ACTUAL participants

Conditions

Type 2 Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Biphasic Remogliflozin Etabonate

DRUG

Placebo

OTHER

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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