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Clinical Trial Details

Trial ID: L1931
Source ID: NCT02836873
Associated Drug: Bexagliflozin
Title: Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02836873/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Bexagliflozin|DRUG: Placebo
Outcome Measures: Primary: 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: Change in Body Weight From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2, A secondary objective is to evaluate the effect of bexagliflozin 20 mg on the placebo-adjusted change in BMI 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, A secondary objective is to evaluate the effect of bexagliflozin 20 mg on the placebo-adjusted change from baseline in SBP to 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, A secondary objective is to evaluate the effect of bexagliflozin 20 mg on the placebo-adjusted change in HbA1c from baseline 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, A secondary objective is to evaluate the effect of bexagliflozin 20 mg on the placebo-adjusted change in HbA1c from baseline in subjects with stage 3b CKD (eGFR 30 to 44 mL/min/1.73 m2) at week 24., 24 weeks
Sponsor/Collaborators: Sponsor: Theracos
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 312
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-09-23
Completion Date: 2018-01-11
Results First Posted: 2021-04-27
Last Update Posted: 2021-06-30
Locations: Research Site, Fresno, California, 93720, United States|Research Site, La Palma, California, 90623, United States|Research Site, Lincoln, California, 95648, United States|Research Site, Riverside, California, 92505, United States|Research Site, Sacramento, California, 95825, United States|Research Site, San Dimas, California, 91773, United States|Research Site, Monument, Colorado, 80132, United States|Research Site, Norwalk, Connecticut, 06851, United States|Research Site, Hollywood, Florida, 33024, United States|Research Site, Tampa, Florida, 33607, United States|Research Site, West Palm Beach, Florida, 33401, United States|Research Site, Paducah, Kentucky, 42003, United States|Research Site, Auburn, Maine, 04210, United States|Research Site, Rockport, Maine, 04856, United States|Research Site, Nashua, New Hampshire, 03063, United States|Research Site, Bronx, New York, 10461, United States|Research Site, Stow, Ohio, 44224, United States|Research Site, Oklahoma City, Oklahoma, 73112, United States|Research Site, Austin, Texas, 78731, United States|Research Site, Austin, Texas, 78758, United States|Research Site, North Richland Hills, Texas, 76180, United States|Research Site, Round Rock, Texas, 78681, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Dijon, 21079, France|Research Site, Paris, 75010, France|Research Site, Paris, 75013, France|Research Site, Paris, 75877, France|Research Site, Pierre Benite, 69310, France|Research Site, Poitiers, 86021, France|Research Site, Venissieux, 69200, France|Research Site, Atsugi-shi, Kanagawa, 243-0035, Japan|Research Site, Kamakura-shi, Kanagawa, 247-0056, Japan|Research Site, Kawasaki-shi, Kanagawa, 210-0852, Japan|Research Site, Yokohama-shi, Kanagawa, 221-0802, Japan|Research Site, Yokohama-shi, Kanagawa, 231-0023, Japan|Research Site, Yokohama-shi, Kanagawa, 241-0821, Japan|Research Site, Kyoto-shi, Kyoto, 600-8898, Japan|Research Site, Kyoto-shi, Kyoto, 615-8125, Japan|Research Site, Kawagoe-shi, Saitama, 350-0851, Japan|Research Site, Kawaguchi-shi, Saitama, 332-0021, Japan|Research site, Sayama-shi, SAitama, 350-1305, Japan|Research Site, Hachioji-shi, Tokyo, 192-0918, Japan|Research Site, Hachioji-shi, Tokyo, 193-0811, Japan|Research Site, Minato-ku, Tokyo, 108-0075, Japan|Research Site, Ota-ku, Tokyo, 143-0015, Japan|Research Site, Shinagawa-ku, Tokyo, 141-0032, Japan|Research Site, Toshima-ku, Toyko, 171-0021, Japan|Research Site, Alcala de Henares, 28805, Spain|Research Site, Alicante, 03004, Spain|Research Site, Madrid, 28006, Spain|Research Site, Madrid, 28009, Spain|Research Site, Malaga, 29009, Spain|Research Site, Malaga, 29010, Spain|Research Site, Sevilla, 41009, Spain|Research Site, Valencia, 46026, Spain|Research Site, Valencia, 46600, Spain
URL: https://clinicaltrials.gov/show/NCT02836873

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details
D517 Bexagliflozin small molecule DB12236 Details