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Completed

NCT Number: NCT02769481

Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Aschaffenburg, Germany

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About this study

Approximately 420 subjects with inadequately controlled T2DM on metformin will be recruited from North America and Europe. Subjects will be randomly assigned to receive bexagliflozin tablets, 20 mg, or glimepiride capsules, 2, 4 or 6 mg, in a ratio of 1:1 once daily for 96 weeks. Subjects will continue to take metformin for the duration of the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of T2DM
  • Currently taking metformin or taking metformin and one additional oral medication for diabetes
  • Body Mass Index (BMI) ≤ 45 kg/m2
  • Stable dose of blood pressure or cholesterol medications (if applicable) for at least 30 days

Exclusion criteria

  • Hypersensitivity or other contraindication to the safe use of sulfonylurea or glimepiride
  • Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
  • Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs
  • History of genitourinary tract infections
  • Evidence of abnormal liver function
  • Myocardial infarction, stroke or hospitalization for heart failure within 3 months of screening
  • Prior kidney transplant or evidence of kidney problems
  • Pregnant or nursing

Treatment and study plan

Bexagliflozin

Drug

20 mg, tablet

Other names: EGT0001442

Placebo for bexagliflozin

Drug

inactive tablet to match active comparator bexagliflozin

Glimepiride

Drug

2, 4 or 6 mg, capsule

Placebo for glimepiride

Drug

inactive capsules to match active comparator glimepiride

Primary outcomes

  1. Change From Baseline in HbA1c at Week 60

    Time frame: Baseline and Week 60

    The primary objective is to demonstrate that bexagliflozin is non-inferior to glimepiride by evaluating the treatment effect on HbA1c reduction at week 60 in subjects whose T2DM is inadequately controlled by metformin. The least square mean (LSM) change from baseline to Week 60 was analyzed using a mixed model repeated measures (MMRM) analysis of covariance model (ANCOVA).

Secondary outcomes

  1. Change From Baseline in Body Weight at Week 60 for Subjects With Baseline BMI ≥ 25 kg/m2

    Time frame: Baseline and 60 weeks

    Least squares (LS) mean treatment difference between the bexagliflozin group and placebo group in the change of body weight in subjects with baseline BMI ≥ 25 kg/m2 at week 60 is analyzed using ANCOVA.

  2. Change From Baseline in Systolic Blood Pressure (SBP) at Week 60 for Subjects With Baseline SBP ≥ 140 mmHg

    Time frame: Baseline and 60 weeks

    Least squares (LS) mean treatment difference between the bexagliflozin group and placebo group in the change of SBP in subjects with baseline SBP ≥ 140 mmHg at week 60 is analyzed using ANCOVA.

  3. Difference in Proportion of Subjects With ≥ 1 Severe or Documented Symptomatic Hypoglycemia Events Over 96 Weeks

    Time frame: During the 96 week treatment period

    The difference in proportion of subjects with ≥ 1 severe or documented symptomatic hypoglycemia events in the bexagliflozin group compared with glimepiride group over 96 weeks is analyzed using a logistic regression model. The full model included region, baseline HbA1c value, background treatment status (metformin or metformin + OHA), eGFR at baseline ≥ 90 or < 90 mL min 1 per 1.73 m2), treatment as a fixed effect covariate.

  4. Superiority of Bexagliflozin Over Glimepiride in HbA1c Reduction at Week 60.

    Time frame: Baseline to Week 60

    Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% CI is less than 0.

Sponsors and collaborators

Lead sponsor

Theracos

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 11, 2016
Registry last updated
May 27, 2021

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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