Clinical Trial Details
| Trial ID: | L4099 |
| Source ID: | NCT02715258 |
| Associated Drug: | Bexagliflozin |
| Title: | Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02715258/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Bexagliflozin|DRUG: Placebo |
| Outcome Measures: | Primary: Change in HbA1c From Baseline at Week 24, Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method., 24 weeks | Secondary: Change in Systolic Blood Pressure (SBP) From Baseline at Week 24, Blood pressure (BP) measurements are obtained using a calibrated sphygmomanometer in sitting, supine and standing positions. The left arm and same cuff sizes should be used for each measurement at all visits. If the left arm cannot be used at the screening visit or during the study for BP measurements, the reason should be documented and the right arm should be used for BP measurements for all subsequent visits., 24 weeks|Change in Body Weight From Baseline at Week 24 in Subjects With a BMI ≥ 25 Kg/m2, The body weight was obtained using a calibrated scale as part of complete physical examination or abbreviated physical examination., 24 weeks | Other: Change From Baseline in Fasting Plasma Glucose (FPG) Over Time, The fasting plasma glucose (FPG) is measured at each study visit. The subject must have fasted for approximately 10 hours prior to the blood draw to ensure that the FPG value is truly a fasting sample., 24 weeks|Change From Baseline of HbA1c From Baseline Over Time, Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method., 24 weeks|Proportion of Subjects Who Achieve an HbA1c < 7%, Glycated hemoglobin A1c (%) was measured using an HPLC method in the laboratories that had completed NGSP Level I laboratory certification and were traceable to the Diabetes Control and Complications Trial (DCCT) reference method., Up to 24 weeks |
| Sponsor/Collaborators: | Sponsor: Theracos |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 210 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2016-03 |
| Completion Date: | 2017-04 |
| Results First Posted: | 2021-04-28 |
| Last Update Posted: | 2021-06-28 |
| Locations: | Research Site, Canoga Park, California, 91303, United States|Research Site, Chino, California, 91710, United States|Research Site, Huntington Park, California, 90255, United States|Research Site, Los Angeles, California, 90057, United States|Research Site, San Diego, California, 92103, United States|Research Site, Fort Lauderdale, Florida, 33316, United States|Research Site, Hialeah, Florida, 33012, United States|Research Site, Miami Lakes, Florida, 33016, United States|Research Site, Orlando, Florida, 32806, United States|Research Site, Port Orange, Florida, 32127, United States|Research Site, Trenton, New Jersey, 08611, United States|Research Site, Calabash, North Carolina, 28467, United States|Research Site, Morehead City, North Carolina, 28557, United States|Research Site, Munroe Falls, Ohio, 44262, United States|Research Site, Portland, Oregon, 97239, United States|Research Site, North Myrtle Beach, South Carolina, 29582, United States|Research Site, DeSoto, Texas, 75115, United States|Research Site, Fort Worth, Texas, 76164, United States|Research Site, Vancouver, British Columbia, V6J 1S3, Canada|Research Site, Newmarket, Ontario, L3Y 5G8, Canada|Research Site 2, Toronto, Ontario, M9V 4B4, Canada|Research Site 1, Toronto, Ontario, M9W 4L6, Canada|Research Site, Pointe-Claire, Quebec, H9R 4S3, Canada |
| URL: | https://clinicaltrials.gov/show/NCT02715258 |
