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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02537470

Run by

BHV Pharma

People needed

191

Starts

2015-07-01

Expected to finish

2016-08-01

Last updated by the study team

2018-01-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide written informed consent
• Subject with clinical diagnosis of type 2 diabetes
• HbA1c 7.0 - 10.5% inclusive at Visit 1.

You may not qualify if…

• 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.

Where it is running

• 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
• eStudySite, Las Vegas — Las Vegas, Nevada, United States
• Comprehensive Clinical Research — Berlin, New Jersey, United States
• Albuquerque Clinical Trials, Inc — Albuquerque, New Mexico, United States
• Mountain View Clinical Research — Greer, South Carolina, United States
• New Phase Research & Development — Knoxville, Tennessee, United States
• Austin Center for Clinical Research — Austin, Texas, United States
• Padre Coast Clinical Research — Corpus Christi, Texas, United States
• Juno Research, LLC — Houston, Texas, United States
• Wasatch Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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