- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02715258
Safety and Efficacy of Bexagliflozin as Monotherapy in Patients With Type 2 Diabetes
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Compare the Efficacy and Safety of Bexagliflozin to Placebo in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6J 1S3
- Research Site
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Ontario
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Newmarket, Ontario, Canada, L3Y 5G8
- Research Site
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Toronto, Ontario, Canada, M9V 4B4
- Research Site 2
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Toronto, Ontario, Canada, M9W 4L6
- Research Site 1
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Quebec
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Pointe-Claire, Quebec, Canada, H9R 4S3
- Research Site
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California
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Canoga Park, California, United States, 91303
- Research Site
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Chino, California, United States, 91710
- Research Site
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Huntington Park, California, United States, 90255
- Research Site
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Los Angeles, California, United States, 90057
- Research Site
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San Diego, California, United States, 92103
- Research Site
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Research Site
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Hialeah, Florida, United States, 33012
- Research Site
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Miami Lakes, Florida, United States, 33016
- Research Site
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Orlando, Florida, United States, 32806
- Research Site
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Port Orange, Florida, United States, 32127
- Research Site
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New Jersey
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Trenton, New Jersey, United States, 08611
- Research Site
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North Carolina
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Calabash, North Carolina, United States, 28467
- Research Site
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Morehead City, North Carolina, United States, 28557
- Research Site
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Ohio
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Munroe Falls, Ohio, United States, 44262
- Research Site
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Oregon
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Portland, Oregon, United States, 97239
- Research Site
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South Carolina
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North Myrtle Beach, South Carolina, United States, 29582
- Research Site
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Texas
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DeSoto, Texas, United States, 75115
- Research Site
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Fort Worth, Texas, United States, 76164
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The study population included:
- Male or female adult subjects ≥ 18 years of age at screening
- Subjects who were treatment naïve or receiving 1 OHA in combination with diet and exercise
- Subjects with a diagnosis of T2DM
- Subjects with HbA1c levels at screening between 7.0% and 10.5% (inclusive) if treatment-naïve or with HbA1c levels between 6.5 and 10.0% (inclusive) if on 1 oral anti diabetic agent
- Subjects with a BMI ≤ 45 kg/m2
- Subjects whose doses of medications for hypertension or hyperlipidemia (if applicable) had not changed for at least 30 days prior to screening
- Subjects who were willing and able to return for all clinic visits and to complete all study required procedures
- Female subjects of childbearing potential who were willing to use an adequate method of contraception and not become pregnant for the duration of the study.
- Subjects who maintained glycemic control throughout washout, if applicable.
- Subjects who had HbA1c levels between 7.0 and 10.5% prior to randomization
- Subjects who had been compliant in investigational product administration by missing no more than 1 dose of run-in medication
Subjects who met any of the following criteria were excluded from the study:
- A diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of the young
- Use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor agonist therapy) or thiazolidinedione class drugs at the time of screening
- Female subjects who were pregnant or breastfeeding
- Hemoglobinopathy or carrier status for hemoglobin alleles that affected HbA1c measurement
- Genitourinary tract infection (e.g., UTI, GMI, vaginitis, balanitis) within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within 6 months from screening
- Estimated glomerular filtration rate (eGFR), as calculated by the modification of diet in renal disease study equation (MDRD), < 60 mL/min/1.73 m2 at screening
- Uncontrolled hypertension defined as a sitting systolic blood pressure >160 mm Hg or diastolic blood pressure > 95 mm Hg at screening
- A positive result for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV)
- History of alcohol or illicit drug abuse in the past 2 years
- Known human immunodeficiency virus (HIV) positive based on medical history
- Life expectancy < 2 years
- New York Heart Association (NYHA) Class IV heart failure within 3 months of screening
- MI, unstable angina, stroke, or hospitalization for heart failure within 3 months of screening
- Treatment with an investigational drug within 30 days or within 7 half-lives of the investigational drug, whichever was longer
- Previous treatment with bexagliflozin or EGT0001474
- Use of any SGLT2 inhibitors, either at the time of screening or in the prior 3 months
- Currently participating in another interventional trial
- Not able to comply with the study scheduled visits
- Any condition, disease, disorder, or clinically relevant abnormality that, in the opinion of the primary investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x ULN or total bilirubin ≥ 1.5 x upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome at screening
- Two or more consecutive FPG measures ≥ 250 mg/dL (13.9 mmol/L) prior to randomization or severe clinical signs or symptoms of hyperglycemia during the washout or run-in periods, including weight loss, blurred vision, increased thirst, or increased urination, or fatigue
- At last visit prior to randomization, FPG level ≥ 250 mg/dL
- Prior renal transplantation or evidence of nephrotic syndrome (defined as a urine albumin-to-creatinine ratio (UACR) > 2000 mg/g at screening).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Bexagliflozin tablets, 20 mg
Each subject will self-administer bexagliflozin tablets once daily for 24 weeks.
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tablets containing 20 mg bexagliflozin
Other Names:
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Placebo Comparator: Placebo tablets
Each subject will self-administer placebo (inactive tablet) once daily for 24 weeks.
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tablets matching the appearance of bexagliflozin tablets
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1c From Baseline at Week 24
Time Frame: 24 weeks
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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.
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Systolic Blood Pressure (SBP) From Baseline at Week 24
Time Frame: 24 weeks
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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.
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24 weeks
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Change in Body Weight From Baseline at Week 24 in Subjects With a BMI ≥ 25 Kg/m2
Time Frame: 24 weeks
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The body weight was obtained using a calibrated scale as part of complete physical examination or abbreviated physical examination.
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24 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Fasting Plasma Glucose (FPG) Over Time
Time Frame: 24 weeks
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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.
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24 weeks
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Change From Baseline of HbA1c From Baseline Over Time
Time Frame: 24 weeks
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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.
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24 weeks
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Proportion of Subjects Who Achieve an HbA1c < 7%
Time Frame: Up to 24 weeks
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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.
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Up to 24 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THR-1442-C-450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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