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Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836873
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Theracos

Study Description
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Brief Summary:
The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and moderate renal impairment.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Bexagliflozin Drug: Placebo Phase 3

Detailed Description:
Approximately 52 investigative site globally are planned to participate in this study. An estimated 300 subjects with poorly controlled T2DM and moderate renal impairment will be randomly assigned to receive bexagliflozin tablets, 20 mg, or placebo in equal ratio for 24 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Study to Evaluate the Effect of Bexagliflozin Tablets on Hemoglobin A1c in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment
Actual Study Start Date : September 23, 2016
Actual Primary Completion Date : January 11, 2018
Actual Study Completion Date : January 11, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bexagliflozin tablets, 20 mg
Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.
 Drug: Bexagliflozin
Bexagliflozin tablet, 20 mg
Other Names:
  • EGT0001442
  • EGT0001474
Placebo Comparator: Placebo tablets
Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.
 Drug: Placebo
Placebo (inactive) tablet to match the active comparator


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c at 24 weeks [ Time Frame: 24 weeks ]
    The primary efficacy objective of this trial is to evaluate the placebo-adjusted change in HbA1c from baseline after 24 weeks of treatment with 20 mg bexagliflozin tablets in type 2 diabetic subjects with moderate renal impairment.


Secondary Outcome Measures :
  1. Change in body weight at 24 weeks in subjects with baseline body mass index (BMI) ≥ 25 kg/m [ Time Frame: 24 weeks ]
    A secondary objective is to evaluate the effect of 20 mg bexagliflozin on the placebo-adjusted change in BMI from baseline to week 24 in subjects with a BMI ≥ 25 kg/m2.

  2. Change in systolic blood pressure (SBP) at 24 weeks in subjects with baseline SBP ≥ 130 mmHg [ Time Frame: 24 weeks ]
    A secondary objective is to evaluate the effect of 20 mg bexagliflozin on the placebo-adjusted change in SBP from baseline to week 24 in subjects with baseline SBP ≥ 130 mmHg.

  3. Change in HbA1c at 24 weeks in subjects with eGFR 45 to 59 mL/min/1.73 m2 at week 24 [ Time Frame: 24 weeks ]
    A secondary objective is to evaluate the effect of 20 mg bexagliflozin on the placebo-adjusted change in HbA1c from baseline to week 24 in subjects with eGFR 45 to 59 mL/min/1.73 m2 at week 24.

  4. Change in HbA1c at 24 weeks in subjects with eGFR 30 to 44 mL/min/1.73 m2 at week 24 [ Time Frame: 24 weeks ]
    A secondary objective is to evaluate the effect of 20 mg bexagliflozin on the placebo-adjusted change in HbA1c from baseline to week 24 in subjects with eGFR 30 to 44 mL/min/1.73 m2 at week 24.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females with T2DM with inadequate glycemic control
  2. Diagnosis of moderate renal impairment

4) Body Mass Index ≤ 45 kg/m2

Exclusion Criteria:

  1. Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
  2. Women who are pregnant or nursing
  3. Subjects who are receiving renal replacement therapy or have undergone renal transplantation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836873


Locations
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Sponsors and Collaborators
Theracos
Investigators
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Study Director: Andrew Allegretti, M.D. Massachusetts General Hospital
More Information
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Responsible Party: Theracos
ClinicalTrials.gov Identifier: NCT02836873    
Other Study ID Numbers: THR-1442-C-448
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases