Sreenan S, Virkamäki A, Zhang K, Hansen J B
Department of Endocrinology, Connolly Hospital, Dublin, Ireland.
Int J Clin Pract. 2008 Dec;62(12):1971-80. doi: 10.1111/j.1742-1241.2008.01939.x.
The PREDICTIVE study is a multinational observational study designed to follow up patients with diabetes who started insulin detemir (IDet) in routine care. Recruitment started in June 2004 and is ongoing in some countries.
We report 12-week follow-up data for patients with type 1 (T1D) or type 2 diabetes (T2D) in the European cohort who, as part of basal-bolus therapy, switched from once- (qd) or twice-daily (bid) neutral protamine Hagedorn insulin (NPH) to qd IDet. End-points - evaluated from patients' records and diaries - were incidence of serious adverse drug reactions, glycaemic parameters, hypoglycaemia and weight change.
A total of 3637 patients were included, n = 1500 T1D [mean age 40.9 years, body mass index (BMI) 25.0 kg/m(2), glycosylated haemoglobin (HbA(1c)) 7.9%] and n = 2137 T2D (mean age 60.5 years, BMI 31.9 kg/m(2), HbA(1c) 8.0%). IDet was well tolerated. Lower overall, major and nocturnal rates of hypoglycaemia were observed in T1D and T2D patients switching from NPH to IDet (overall, T1D: 38.2-18.56 episodes/patient year, p < 0.001; T2D: 13.8-3.3 [corrected] episodes/patient year, p < 0.001). Switching from bid NPH to qd IDet resulted in significant 12-week reductions in HbA(1c) (T1D: -0.40%; T2D: -0.56%; both p < 0.001). Switching from qd NPH to qd IDet, resulted in HbA(1c) reductions of: T1D -0.52%; T2D -0.56%; both p < 0.001. Fasting blood glucose levels were also significantly reduced in patients with T1D or T2D. Overall mean weight changes were: T1D: 0.0 kg, T2D: -0.2 kg after 12 weeks.
In routine care, patients with T1D or T2D may be switched from NPH to IDet qd as part of a basal-bolus regimen.
PREDICTIVE研究是一项跨国观察性研究，旨在对在常规治疗中开始使用地特胰岛素（IDet）的糖尿病患者进行随访。招募工作于2004年6月开始，在一些国家仍在进行。
我们报告了欧洲队列中1型糖尿病（T1D）或2型糖尿病（T2D）患者的12周随访数据，这些患者作为基础-餐时胰岛素治疗的一部分，从每日一次（qd）或每日两次（bid）的中性鱼精蛋白锌胰岛素（NPH）转换为每日一次的IDet。通过患者记录和日记评估的终点指标包括严重药物不良反应的发生率、血糖参数、低血糖和体重变化。
共纳入3637例患者，其中1500例为T1D患者[平均年龄40.9岁，体重指数（BMI）25.0kg/m²，糖化血红蛋白（HbA1c）7.9%]，2137例为T2D患者（平均年龄60.5岁，BMI 31.9kg/m²，HbA1c 8.0%）。IDet耐受性良好。从NPH转换为IDet的T1D和T2D患者低血糖的总体、严重和夜间发生率均较低（总体，T1D：38.2 - 18.56次/患者年，p < 0.
