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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:20 - Any
Updated:12/22/2018
Start Date:September 23, 2016
End Date:January 11, 2018

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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

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.

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.

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
We found this trial at
23
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La Palma, CA
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Auburn, ME
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Lincoln, CA
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1864 Woodmoor Drive
Monument, Colorado 80132
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Monument, CO
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Nashua, NH
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North Richland Hills, Texas 76180
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North Richland Hills, TX
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Norwalk, CT
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Riverside, CA
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Rockport, ME
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Round Rock, TX
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San Dimas, CA
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Stow, OH
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Tampa, FL
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West Palm Beach, FL
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