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学科主题: 临床医学
题名:
The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration
作者: Gao, Yan1; Luquez, Cecilia2; Lynggaard, Helle3; Andersen, Henning3; Saboo, Banshi4
关键词: Biphasic insulin aspart 30 ; HbA1c ; Titration
刊名: CURRENT MEDICAL RESEARCH AND OPINION
发表日期: 2014-12-01
DOI: 10.1185/03007995.2014.960512
卷: 30, 期:12, 页:2483-2492
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal ; Medicine, Research & Experimental
研究领域[WOS]: General & Internal Medicine ; Research & Experimental Medicine
关键词[WOS]: HEALTH LITERACY ; PRIMARY-CARE ; DIABETES-MELLITUS ; GLYCEMIC CONTROL ; SELF-TITRATION ; THERAPY ; COMPLICATIONS ; ASSOCIATION ; TYPE-1
英文摘要:

Objective:

The study aimed to confirm the efficacy, through non-inferiority, of patient-driven versus investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) in terms of glycemic control assessed by HbA1c change.

Methods:

SimpleMix was a 20 week, open-label, randomized, two-armed, parallel-group, multicenter study in five countries (Argentina, China, India, Poland, and the UK). Patients with type 2 diabetes were randomized into either patient-driven or investigator-driven BIAsp 30 titration groups.

Results:

Non-inferiority of patient-driven vs. investigator-driven titration based on change in HbA1c from baseline to week 20 could not be demonstrated. Mean (SE) estimated change from baseline to week 20 was -0.72 (0.08)% in the patient-driven group and -0.97 (0.08)% in the investigator-driven group; estimated difference 0.25% (95% CI: 0.04; 0.46). Estimated mean change (SE) in fasting plasma glucose from baseline to week 20 was similar between groups: -0.94 (0.21) mmol/L for patient-driven and -1.07 (0.22) mmol/L for investigator-driven (difference non-significant). Both treatment arms were well tolerated, and hypoglycemic episode rates were similar between groups, with a rate ratio of 0.77 (95% CI: 0.54; 1.09; p = 0.143) for all hypoglycemic episodes and 0.78 (95% CI: 0.42; 1.43; p = 0.417) for nocturnal hypoglycemic episodes.

Conclusions:

Non-inferiority of patient-driven versus investigator-driven titration with regard to change from baseline to end-of-treatment HbA1c could not be confirmed. It is possible that a clinic visit 12 weeks after intensification of treatment with BIAsp 30 in patients with type 2 diabetes inadequately treated with basal insulin may benefit patient-driven titration of BIAsp 30. A limitation of the study was the relatively small number of patients recruited in each country, which does not allow country-specific analyses to be performed. Overall, treatment with BIAsp 30 was well tolerated in both treatment groups.

语种: 英语
项目资助者: Novo Nordisk A/S, Denmark
WOS记录号: WOS:000345602300012
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/51665
Appears in Collections:北京大学第一临床医学院_内分泌内科_期刊论文

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作者单位: 1.Ctr Med Luquez, Serv Diabetol, Cordoba, Argentina
2.Novo Nordisk AS, Med & Sci, Bagsvaerd, Denmark
3.Dia Care Diabet Care & Hormone Clin, Ahmadabad, Gujarat, India
4.Peking Univ, Hosp 1, Dept Endocrinol, Beijing 100871, Peoples R China

Recommended Citation:
Gao, Yan,Luquez, Cecilia,Lynggaard, Helle,et al. The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration[J]. CURRENT MEDICAL RESEARCH AND OPINION,2014,30(12):2483-2492.
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