Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes
- Registration Number
- NCT02715258
- Lead Sponsor
- Theracos
- Brief Summary
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).
- Detailed Description
This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of once daily oral administration of bexagliflozin tablets, 20 mg or placebo tablets, in male and female subjects with T2DM who were treatment-naïve or previously treated with 1 oral hypoglycemic agent (OHA).
Prospective subjects being treated with one OHA were eligible if they had an HbA1c between 6.5% and 10.0% and were willing to complete a 6-week washout. Individuals taking thiazolidinediones were not eligible for the study. All eligible subjects were to start a 2-week placebo run-in period. Subjects who missed no more than 1 dose of the run-in medication, had fasting blood glucose values ≥ 250 mg/dL on no more than two consecutive days, and had an HbA1c level between 7.0% and 10.5% and a fasting glucose level \< 250 mg/dL after the run-in period were eligible for randomization.
Two hundred and ten (210) subjects were planned to be randomly assigned to receive oral bexagliflozin tablets, 20 mg or placebo, in a 2:1 ratio once daily for 24 weeks. Subjects with uncontrolled hyperglycemia based on blood glucose levels could receive additional approved anti-diabetic medications. Treatment group assignment at the start of the treatment period was stratified by baseline HbA1c level and background anti-diabetes treatment status (treatment naïve or not).
Each subject was contacted by telephone at week 2 and was instructed to return to the clinic at weeks 6, 12, 18, and 24 for efficacy assessment and safety monitoring. Subjects returned to the clinic for a follow-up visit at week 26 or 2 weeks after the last dose of investigational product if the subject terminated prior to week 24.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo tablets Placebo Each subject will self-administer placebo (inactive tablet) once daily for 24 weeks. Bexagliflozin tablets, 20 mg Bexagliflozin Each subject will self-administer bexagliflozin tablets once daily for 24 weeks.
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline at Week 24 24 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in Body Weight From Baseline at Week 24 in Subjects With a BMI ≥ 25 Kg/m2 24 weeks The body weight was obtained using a calibrated scale as part of complete physical examination or abbreviated physical examination.
Change in Systolic Blood Pressure (SBP) From Baseline at Week 24 24 weeks 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.
Trial Locations
- Locations (3)
Research Site
🇨🇦Pointe-Claire, Quebec, Canada
Research Site 2
🇨🇦Toronto, Ontario, Canada
Research Site 1
🇨🇦Toronto, Ontario, Canada