Safety and Efficacy of Bexagliflozin Compared to Sitagliptin as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/21/2018 |
| Start Date: | October 12, 2017 |
| End Date: | August 15, 2018 |
A Phase 3, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Effects of Bexagliflozin Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin
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).
sitagliptin as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in
subjects with type 2 diabetes mellitus (T2DM).
Approximately 374 subjects with inadequately controlled T2DM on metformin will be recruited
from North America and Europe. Subjects will be randomly assigned in a ratio of 1:1 to
receive either bexagliflozin tablets, 20 mg, or sitagliptin tablets,100mg, once daily for 24
weeks. Subjects will continue to take metformin for the duration of the study.
from North America and Europe. Subjects will be randomly assigned in a ratio of 1:1 to
receive either bexagliflozin tablets, 20 mg, or sitagliptin tablets,100mg, once daily for 24
weeks. Subjects will continue to take metformin for the duration of the study.
Inclusion Criteria:
- Diagnosis of T2DM
- Currently taking metformin or taking metformin and one additional oral medication for
diabetes
- Body Mass Index (BMI) ≤ 45 kg/m2
- Stable dose of blood pressure or cholesterol medications (if applicable) for at least
30 days
Exclusion Criteria:
- Hypersensitivity or other contraindication to the safe use of DPP-4 inhibitor or
sitagliptin
- Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
- History of genitourinary tract infections
- Evidence of abnormal liver function
- History of pancreatitis
- Myocardial infarction, stroke or hospitalization for heart failure within 3 months of
screening
- Evidence of kidney problems
- Pregnant or nursing
We found this trial at
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