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J Diabetes. 2016 Nov;8(6):809-815. doi: 10.1111/1753-0407.12360. Epub 2016 Mar 6.

Efficacy and safety of saxagliptin monotherapy or added to metformin in Chinese patients with type 2 diabetes mellitus: results from the 24-week, post-marketing SUNSHINE study.

Author information

1
Ruijin Hospital, Shanghai.
2
People's Hospital of Liaoning Province.
3
Linyi People's Hospital, Linyi.
4
The First Affiliated Hospital of Baotou Medical College, Baotou.
5
Hospital 463 of PLA.
6
Fengtian Hospital Affiliated to Shenyang Medical College, Shenyang.
7
The Second Affiliated Hospital of Chongqing Medical University.
8
The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun.
9
Dongguan Guanghua Hospital, Dongguan.
10
Tianjin Third Hospital, Tianjin.
11
Peking Union Medical College Hospital, Beijing, China.
12
Chongqing Ninth Hospital, Chongqing.
13
Ruijin Hospital, Shanghai. wqingw@hotmail.com.

Abstract

BACKGROUND:

The aim of the present study was to explore the efficacy and safety of saxagliptin in a large Chinese population with type 2 diabetes mellitus (T2DM).

METHODS:

In all, 1423 T2DM patients from 92 research centers, either drug naïve or uncontrolled by metformin, were enrolled in this single-arm cohort study; patients were treated with saxagliptin 5 mg once daily for 24 weeks. The primary efficacy endpoint was the change from baseline in HbA1c at 24 weeks in the per-protocol analysis set. Secondary endpoints included the proportion of patients achieving HbA1c <7% and changes from baseline in fasting plasma glucose (FPG) and 2-h postprandial plasma glucose (PPG) concentrations at 24 weeks. Safety endpoints included adverse events (AEs) and the incidence of hypoglycemia.

RESULTS:

Among 1210 patients in the per-protocol analysis set, mean HbA1c, FPG and 2-h PPG decreased by 1.61 ± 0.04%, 0.55 ± 0.07 mmol/L, and 2.83  ±  0.27 mmol/L, respectively, at week 24. The proportion of patients achieving HbA1c <7% was 44.1%. No new (previously unreported) AEs occurred. The incidence of serious AEs and hypoglycemia was low (1.8% and 1.2%, respectively). There were no significant differences in efficacy endpoints in subgroup analyses by age, creatinine clearance, body mass index, or treatment background. In elderly patients (≥65 years) and those with mild renal impairment (50 < CCr ≤ 80 mL/min), the incidence of AEs was similar to that of the entire study population.

CONCLUSIONS:

Saxagliptin significantly improved glycemic control and was well tolerated in Chinese T2DM patients, including the elderly and patients with mild renal impairment.

KEYWORDS:

2型糖尿病; efficacy; safety; saxagliptin; type 2 diabetes mellitus; 安全性; 沙格列汀; 疗效

PMID:
26676908
DOI:
10.1111/1753-0407.12360
[Indexed for MEDLINE]

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