Biphasic insulin aspart 30 improved glycemic control in Chinese patients with type 2 diabetes poorly controlled on oral glucose-lowering drugs: a subgroup analysis of the A₁chieve study.
BACKGROUND
The effectiveness and safety of initiating biphasic insulin aspart 30 in patients who were poorly controlled on oral glucose-lowering drugs were studied in randomized controlled trials, while results from clinical practice remain limited. This subgroup analysis was to provide such findings from a large-scale non-interventional study.


METHODS
A1chieve was a multinational, prospective, open-label, non-interventional, 24-week study in patients with type 2 diabetes initiating insulin analogues in 28 countries across Asia, Africa, Europe, and Latin America. After physician had taken the decision to use this insulin, any patient with type 2 diabetes who was not treated with or who had started the study insulin within 4 weeks before inclusion was eligible. Patients were treated with study insulin alone or in combination with oral glucose-lowering drugs. Data on adverse drug reactions, hypoglycemia and glycemic control were collected at baseline, week 12 and 24. This is a report of a Chinese subgroup analysis from the A1chieve study.


RESULTS
Totally, 4 100 patients constituted this subgroup. No serious adverse drug reactions were reported. Rates of total, major, nocturnal hypoglycemic events (events/patient per year) were 1.47, 0.10, 0.31 at baseline and 1.35, 0.00, 0.22 at week 24, respectively. Glycemic control was improved as measured by hemoglobin A1c (mean 9.3% to 7.0%, reduction -2.3%), fasting plasma glucose (mean 10.2 to 6.8 mmol/L, reduction -3.5 mmol/L) and postprandial plasma glucose (mean 14.4 to 8.8 mmol/L, reduction -5.6 mmol/L), all P < 0.001. Change in mean body weight was +0.3 kg (P < 0.001).


CONCLUSIONS
In this subgroup analysis of the A1chieve study, biphasic insulin aspart 30 improved glycemic control with low risk of hypoglycemia.
Key Laboratory of Hormones and Development (Ministry of Health), Metabolic Diseases Hospital & Tianjin Institute of Endocrinology, Tianjin Medical University, Tianjin 300070, China.
Liming
L
Chen
Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China.
Xiaoyan
X
Xing
Department of Endocrinology, Xiangya Hospital of Central South University, Changsha, Hunan 410008, China.
Minxiang
M
Lei
Department of Endocrinology, Shanxi Provincial People's Hospital, Taiyuan, Shanxi 030012, China.
Jie
J
Liu
Department of Endocrinology, Shanghai Changzheng Hospital, Shanghai 200032, China.
Yongquan
Y
Shi
Sichuan Provincial People's Hospital, Chengdu, Sichuan 610072, China.
Pengqiu
P
Li
Department of Endocrinology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, China.
Guijun
G
Qin
Department of Endocrinology, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310003, China.
Chengjiang
C
Li
Department of Endocrinology, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei 050051, China.
Yukun
Y
Li
Department of Endocrinology, China-Japan Union Hospital, Changchun, Jilin 130033, China.
Qing
Q
Wang
Department of Endocrinology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning 110032, China.
Tianshu
T
Gao
Department of Endocrinology, Third Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330008, China.
Ling
L
Hu
Department of Endocrinology, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi 710068, China.
Yangwei
Y
Wang
Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China. Email: ywying_1010@163.com.
Wenying
W
Yang
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D061265:Biphasic Insulins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose / Q000187:drug effects*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D061267:Insulin Aspart / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D061267:Insulin Aspart; D007336:Insulin, Isophane; C557564:insulin aspart, insulin aspart protamine drug combination 30:70