Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
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ClinicalTrials.gov Identifier: NCT02836873 |
Recruitment Status :
Completed
First Posted : July 19, 2016
Last Update Posted : October 9, 2019
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Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes Mellitus | Drug: Bexagliflozin Drug: Placebo | Phase 3 |
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 |

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

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males or females with T2DM with inadequate glycemic control
- Diagnosis of moderate renal impairment
4) Body Mass Index ≤ 45 kg/m2
Exclusion Criteria:
- Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
- Women who are pregnant or nursing
- Subjects who are receiving renal replacement therapy or have undergone renal transplantation

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

Study Director: | Andrew Allegretti, M.D. | Massachusetts General Hospital |
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 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |