|The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration|
|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|
|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|
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.
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.
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.
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.
|资助机构||Novo Nordisk A/S, Denmark|
|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
|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.|
|APA||Gao, Yan,Luquez, Cecilia,Lynggaard, Helle,Andersen, Henning,&Saboo, Banshi.(2014).The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration.CURRENT MEDICAL RESEARCH AND OPINION,30(12),2483-2492.|
|MLA||Gao, Yan,et al."The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration".CURRENT MEDICAL RESEARCH AND OPINION 30.12(2014):2483-2492.|