The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.
A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,165
oral, 5 mg once a day (Q.D.)
Research Site
Baotou, China
Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.
Time frame: Weeks 6, 12, and 24
Proportion (%) of Patients Achieving HbA1c <7%
Time frame: Weeks 6, 12, and 24
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Weeks 6, 12, 18, and 24
Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)
Time frame: Week 24
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Research Site
Beijing, China
Research Site
Benxi, China
Research Site
Changchun, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Dalian, China
Research Site
Dongguan, China
Research Site
Foshan, China
Research Site
Fuzhou, China
...and 27 more locations