Bhargava Anuj, Chan Vicky, Kimball Edward S, Oyer David S
Iowa Diabetes and Endocrinology Research Center, 411 Laurel Street, Suite 3262, Des Moines, IA, 50314, USA.
Novo Nordisk Inc., Princeton, NJ, USA.
Drugs Aging. 2016 Feb;33(2):135-41. doi: 10.1007/s40266-016-0342-9.
This post-hoc sub-analysis investigated whether age (<65 years vs ≥65 years) affects glycemic control or hypoglycemic risk in patients with type 2 diabetes mellitus (T2DM) treated with once-daily insulin detemir.
This was a 26-week, randomized, open-label, phase IV trial involving 2812 patients at 1083 predominantly primary care sites throughout the United States, of which 541 were designated for investigator-led insulin titration. The main efficacy measure was change in HbA1c (A1C) from baseline to Week 26. Patients were stratified by age in the sites designated for the investigator-led titration of insulin detemir. Safety measures included adverse events and change in hypoglycemic event rates from baseline to Week 26.
At Week 26, mean A1C and fasting plasma glucose decreased in both groups, but mean differences in change from baseline were not significant between groups. Within the group ≥65 years, significant reductions occurred for all daytime hypoglycemia, but there was no significant change from baseline in the other categories. In the group <65 years, reductions from baseline were significant for all hypoglycemic event categories. Changes in hypoglycemia rates from baseline were not significantly different between the age groups and there was no weight increase in either age group.
This analysis demonstrates that insulin detemir has similar efficacy and safety profiles for patients with T2DM ≥65 years compared with <65 years when treated via an investigator-led algorithm.
这项事后亚组分析调查了年龄（<65岁与≥65岁）是否会影响接受每日一次地特胰岛素治疗的2型糖尿病（T2DM）患者的血糖控制或低血糖风险。
这是一项为期26周的随机、开放标签的IV期试验，涉及美国1083个主要初级保健机构的2812名患者，其中541名患者由研究者主导胰岛素滴定。主要疗效指标是从基线到第26周糖化血红蛋白（HbA1c）的变化。在研究者主导地特胰岛素滴定的机构中，患者按年龄分层。安全指标包括不良事件以及从基线到第26周低血糖事件发生率的变化。
在第26周时，两组患者的平均HbA1c和空腹血糖均下降，但两组间与基线相比的变化均值差异不显著。在≥65岁组中，所有日间低血糖情况均显著减少，但其他类别与基线相比无显著变化。在<65岁组中，所有低血糖事件类别与基线相比均有显著减少。年龄组间从基线开始的低血糖发生率变化无显著差异，且两个年龄组均未出现体重增加。
该分析表明，通过研究者主导的方案治疗时，与<65岁的T2DM患者相比，≥65岁的患者使用地特胰岛素具有相似的疗效和安全性。
