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Completed

NCT Number: NCT02537470

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Arizona Clinical Research, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biphasic Remogliflozin Etabonate

Drug

Experimental Drug

Placebo

Other

Placebo Comparator

Primary outcomes

  1. Glycosylated haemoglobin A1c (HbA1c) at Week 12

    Time frame: 12 weeks

Secondary outcomes

  1. HbA1c

    Time frame: at weeks 4, 8 and 12

  2. Fasting plasma glucose (FPG)

    Time frame: at Weeks 4, 8 and 12

  3. Insulin

    Time frame: at Weeks 4, 8 and 12

  4. C-peptide

    Time frame: at Weeks 4, 8 and 12

  5. Total Cholesterol

    Time frame: at Weeks 4, 8 and 12

  6. LDL-c

    Time frame: at Weeks 4, 8 and 12

  7. HDL-c

    Time frame: at Weeks 4, 8 and 12

  8. Serum Triglycerides

    Time frame: at Weeks 4, 8 and 12

  9. Body Weight

    Time frame: at Weeks 4, 8 and 12

  10. Waist Circumference

    Time frame: at Weeks 4, 8 and 12

  11. Adverse Events (AE)

    Time frame: Over 12 weeks

  12. 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

Sponsors and collaborators

Lead sponsor

BHV Pharma

Industry

Collaborators

  • Integrium

Registry information

Official study 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

Acronym: BRID

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2015
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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