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

NCT02836873 | Completed Phase 3 Results DMC

• 1 other identifier: THR-1442-C-448
• Study Type: interventional
• Target: 312
• Locations: 4 countries
• Sites: 56

Brief Summary

This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of oral administration of bexagliflozin at 20 mg versus placebo in subjects with T2DM, moderate renal impairment and inadequate glycemic control.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at 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.

  24 weeks

Secondary Outcomes (4)

• Change in Body Weight From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2

  24 weeks

• Change From Baseline in Systolic Blood Pressure (SBP) in Subjects With Baseline SBP ≥ 130 mm Hg at Week 24

  24 weeks

• Change From Baseline in HbA1c in Subjects With Stage 3a CKD (eGFR 45 to 59 mL/Min/1.73 m2) at Week 24

  24 weeks

• Change From Baseline in HbA1c in Subjects With Stage 3b CKD (eGFR 30 to 44 mL/Min/1.73 m2) at Week 24

  24 weeks

Study Arms (2)

Bexagliflozin tablets, 20 mg

ACTIVE COMPARATOR

Each subject will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study.

Drug: Bexagliflozin

Placebo tablets

PLACEBO COMPARATOR

Each subject will receive a placebo (inactive) tablet once daily for the duration of the study.

Drug: Placebo

Interventions

Bexagliflozin DRUG

Bexagliflozin tablet, 20 mg

Also known as: EGT0001442, EGT0001474

Bexagliflozin tablets, 20 mg

Placebo DRUG

Placebo (inactive) tablet to match the active comparator

Placebo tablets

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Potential participants who exhibited any of the following characteristics were excluded from the study:
• A diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young (MODY)
• A hemoglobinopathy that could affect HbA1c measurement
• Frequent symptomatic hypoglycemia (greater than one episode per week on average)
• A history of genitourinary tract infection within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within the last 6 months
• A history of alcohol or illicit drug abuse in the past 2 years
• Evidence of abnormal liver function tests (total bilirubin or alkaline phosphatase \> 1.5 × upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × ULN
• A history of MI, stroke or hospitalization for heart failure, or hospitalization for unstable angina in the prior 3 months
• Evidence of NYHA class IV heart failure at screening or randomization
• A history of taking an SGLT2 inhibitor within 3 months of screening
• Any condition, disease, disorder, or clinically relevant laboratory abnormality that, in the opinion of the PI, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment
• A current status of pregnancy or breastfeeding
• A current status of renal replacement therapy (peritoneal or hemodialysis) or a history of renal transplantation
• A corrected serum calcium \< 8 mg dL-1 at screening (V1) or randomization (V3)
• Uncontrolled hypertension (systolic blood pressure \>170 mm Hg or diastolic blood pressure \>110 mm Hg)

Sponsors & Collaborators

• Theracos: lead

Study Sites (56)

Research Site

Fresno, California, 93720, United States

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La Palma, California, 90623, United States

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Lincoln, California, 95648, United States

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Riverside, California, 92505, United States

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Sacramento, California, 95825, United States

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San Dimas, California, 91773, United States

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Monument, Colorado, 80132, United States

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Norwalk, Connecticut, 06851, United States

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Hollywood, Florida, 33024, United States

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Tampa, Florida, 33607, United States

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West Palm Beach, Florida, 33401, United States

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Paducah, Kentucky, 42003, United States

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Auburn, Maine, 04210, United States

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Rockport, Maine, 04856, United States

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Nashua, New Hampshire, 03063, United States

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The Bronx, New York, 10461, United States

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Stow, Ohio, 44224, United States

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Oklahoma City, Oklahoma, 73112, United States

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Austin, Texas, 78731, United States

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Austin, Texas, 78758, United States

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North Richland Hills, Texas, 76180, United States

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Round Rock, Texas, 78681, United States

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San Antonio, Texas, 78229, United States

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Dijon, 21079, France

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Paris, 75010, France

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Paris, 75013, France

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Paris, 75877, France

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Pierre-Bénite, 69310, France

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Poitiers, 86021, France

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Vénissieux, 69200, France

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Atsugi-shi, Kanagawa, 243-0035, Japan

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Kamakura-shi, Kanagawa, 247-0056, Japan

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Kawasaki-shi, Kanagawa, 210-0852, Japan

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Yokohama, Kanagawa, 221-0802, Japan

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Yokohama, Kanagawa, 231-0023, Japan

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Yokohama, Kanagawa, 241-0821, Japan

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Kyoto, Kyoto, 600-8898, Japan

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Kyoto, Kyoto, 615-8125, Japan

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Kawagoe-shi, Saitama, 350-0851, Japan

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Kawaguchi-shi, Saitama, 332-0021, Japan

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Sayama-shi, Saitama, 350-1305, Japan

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Hachioji-shi, Tokyo, 192-0918, Japan

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Hachioji-shi, Tokyo, 193-0811, Japan

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Minato-ku, Tokyo, 108-0075, Japan

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Ōta-ku, Tokyo, 143-0015, Japan

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Shinagawa-ku, Tokyo, 141-0032, Japan

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Toshima-ku, Toyko, 171-0021, Japan

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Alcalá de Henares, 28805, Spain

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Alicante, 03004, Spain

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Madrid, 28006, Spain

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Madrid, 28009, Spain

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Málaga, 29009, Spain

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Málaga, 29010, Spain

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Seville, 41009, Spain

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Valencia, 46026, Spain

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Valencia, 46600, Spain

Location

Related Publications (1)

• Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

  PMID: 38770818 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

bexagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Albert Collinson
• Organization: Theracos Sub, LLC

acollinson@theracos.com

(508) 630-2129

Study Officials

• Andrew Allegretti, M.D.

  Massachusetts General Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 19, 2016
• Study Start: September 23, 2016
• Primary Completion: January 11, 2018
• Study Completion: January 11, 2018
• Last Updated: June 30, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (17); FR (7); US (23); ES (9)