Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03115112
- Lead Sponsor
- Theracos
- Brief Summary
The purpose of this study is to investigate the effect of bexagliflozin compared to sitagliptin as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).
- Detailed Description
This was a phase 3, multi-center, randomized, double-blind, parallel-group study to demonstrate that bexagliflozin was non-inferior to sitagliptin as add-on therapy in subjects whose T2DM was not adequately controlled by metformin treatment alone. The primary effectiveness endpoint was the change in HbA1c from baseline at week 24.
At the time of screening, all subjects were to have taken metformin at a stable dose of ≥ 1500 mg per day for ≥ 8 weeks and have received diet and exercise counseling. A total of 374 eligible subjects were to be enrolled in the study. Subjects who successfully completed a 1-week run-in and who met all eligibility criteria were to be randomized in a 1:1 ratio to receive once daily double-blind treatment of either active bexagliflozin tablets with placebo sitagliptin tablets or placebo bexagliflozin tablets and active sitagliptin tablets. The study subjects were to continue receiving open-labeled metformin during the entire study at a stable dose and frequency. The treatment period was 24 weeks and was conducted in an outpatient setting.
Randomization was stratified by HbA1c (≤ 8.5% vs. ˃ 8.5%) values. Symptoms and blood sugars related to the occurrence of hyperglycemia, hypoglycemic events or symptoms that could indicate ketoacidosis were to be recorded. Bexagliflozin tablets, 20 mg or placebo, and sitagliptin tablets, 100 mg or placebo, were to be taken once daily at approximately the same time each day either before or after breakfast. Background metformin was to be taken at the same dose and frequency from screening throughout the entire study.
Each subject was advised to return to the clinic at weeks 6, 12, 18 and 24 for efficacy assessment and safety monitoring, including review of AEs and concomitant medication, vital signs, ECG, physical examination and blood and urine specimen collections. Subjects were to return to the clinic for a follow-up exit visit at week 26 or 2 weeks after the last dose of study drugs if subjects withdrew from the study prior to week 24.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 386
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitagliptin Sitagliptin Subjects will receive a sitagliptin tablet, 100 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study. Sitagliptin Placebo for bexagliflozin Subjects will receive a sitagliptin tablet, 100 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for bexagliflozin for the duration of the study. Bexagliflozin Placebo for sitagliptin Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for sitagliptin daily for the duration of the study. Bexagliflozin Bexagliflozin Subjects will receive a bexagliflozin tablet, 20 mg, once daily for the duration of the study. Subjects will continue taking metformin and receive placebo for sitagliptin daily for the duration of the study.
- Primary Outcome Measures
Name Time Method Change in HbA1c From Baseline to Week 24 Baseline to week 24 The primary efficacy objective is to demonstrate that bexagliflozin is non-inferior to sitagliptin by evaluating the treatment effect on hemoglobin A1c (HbA1c) reduction at week 24 in subjects whose type 2 diabetes mellitus (T2DM) is inadequately controlled by metformin.
- Secondary Outcome Measures
Name Time Method Change in FPG From Baseline at Week 24 Baseline to week 24 To evaluate the treatment effect of bexagliflozin vs. sitagliptin on the change in fasting plasma glucose (FPG) at week 24
Change in Body Weight in Subjects With Baseline BMI ≥ 25 kg/m2 at Week 24 Baseline to week 24 To evaluate the treatment effect of bexagliflozin vs. sitagliptin on the change in body weight in subjects with baseline body mass index (BMI) ≥ 25 kg/m2 at week 24
Change in SBP in Subjects From Baseline at Week 24 Baseline to week 24 To evaluate the treatment effect of bexagliflozin vs. sitagliptin on the change in systolic blood pressure (SBP) in subjects at week 24
Trial Locations
- Locations (56)
Clinical Research Site 7138
🇵🇱Lublin, Poland
Clinical Research Site 7137
🇵🇱Gdańsk, Poland
Clinical Research Site 7141
🇵🇱Kraków, Poland
Clinical Research Site 9107
🇭🇺Szeged, Hungary
Clinical Research Site 9105
🇭🇺Zalaegerszeg, Hungary
Clinical Research Site 7142
🇵🇱Kraków, Poland
Clinical Research Site 7128
🇵🇱Toruń, Poland
Clinical Research Site 7139
🇵🇱Kraków, Poland
Clinical Research Site 7140
🇵🇱Poznań, Poland
Clinical Research Site 1357
🇺🇸Lincoln, California, United States
Clinical Research Site 1361
🇺🇸San Dimas, California, United States
Clinical Research Site 1271
🇺🇸Chicago, Illinois, United States
Clinical Research Site 3123
🇨🇿Mladá Boleslav, Czechia
Clinical Research Site 3120
🇨🇿Olomouc, Czechia
Clinical Research Site 7144
🇵🇱Kraków, Poland
Clinical Research Site 9013
🇪🇸Barcelona, Spain
Clinical Research Site 9018
🇪🇸Valencia, Spain
Clinical Research Site 6039
🇯🇵Ibaraki, Japan
Clinical Research Site 6038
🇯🇵Tochigi, Japan
Clinical Research Site 7120
🇵🇱Lublin, Poland
Clinical Research Site 1358
🇺🇸Long Beach, California, United States
Clinical Research Site 1359
🇺🇸Topeka, Kansas, United States
Clinical Research Site 1031
🇺🇸Port Orange, Florida, United States
Clinical Research Site 1009
🇺🇸Berlin, New Jersey, United States
Clinical Research Site 1360
🇺🇸San Antonio, Texas, United States
Clinical Research Site 1008
🇺🇸Munroe Falls, Ohio, United States
Clinical Research Site 3119
🇨🇿Hodonín, Czechia
Clinical Research Site 9102
🇭🇺Balatonfüred, Hungary
Clinical Research Site 3122
🇨🇿Prostějov, Czechia
Clinical Research Site 3112
🇨🇿Praha, Czechia
Clinical Research Site 9101
🇭🇺Balatongyörök, Hungary
Clinical Research Site 9103
🇭🇺Zamardi, Hungary
Clinical Research Site 9106
🇭🇺Budapest, Hungary
Clinical Research Site 6042
🇯🇵Chiba, Japan
Clinical Research Site 6037
🇯🇵Chiba, Japan
Clinical Research Site 6040
🇯🇵Fukuoka, Japan
Clinical Research Site 6031
🇯🇵Chiba, Japan
Clinical Research Site 6035
🇯🇵Fukuoka, Japan
Clinical Research Site 6034
🇯🇵Ibaraki, Japan
Clinical Research Site 6041
🇯🇵Ibaraki, Japan
Clinical Research Site 6032
🇯🇵Ibaraki, Japan
Clinical Research Site 6036
🇯🇵Shizuoka, Japan
Clinical Research Site 6033
🇯🇵Ōsaka, Japan
Clinical Research Site 7131
🇵🇱Olsztyn, Poland
Clinical Research Site 7143
🇵🇱Poznań, Poland
Clinical Research Site 7107
🇵🇱Puławy, Poland
Clinical Research Site 7136
🇵🇱Poznań, Poland
Clinical Research Site 9002
🇪🇸Alicante, Spain
Clinical Research Site 9016
🇪🇸Almería, Spain
Clinical Research Site 9005
🇪🇸Alzira, Spain
Clinical Research Site 9017
🇪🇸Barcelona, Spain
Clinical Research Site 9015
🇪🇸Sevilla, Spain
Clinical Research Site 9012
🇪🇸Madrid, Spain
Clinical Research Site 9014
🇪🇸Sevilla, Spain
Clinical Research Site 9011
🇪🇸Sevilla, Spain
Clinical Research Site 1037
🇺🇸Trenton, New Jersey, United States