Dornhorst A, Lüddeke H-J, Koenen C, Meriläinen M, King A, Robinson A, Sreenan S
Department of Metabolic Medicine, Imperial College, London, UK.
Diabetes Obes Metab. 2008 Jan;10(1):75-81. doi: 10.1111/j.1463-1326.2007.00816.x. Epub 2007 Nov 22.
The aim of this study was to evaluate the safety and efficacy of insulin detemir in type 2 diabetes patients previously receiving NPH insulin (NPH group, n = 175) or insulin glargine (glargine group, n = 118) in combination with oral antidiabetic drugs (OADs).
Patients were transferred to insulin detemir, while the OAD regimen and number of injections remained the same. The incidence of serious adverse drug reactions, including major hypoglycaemia, and haemoglobin A(1c) (HbA(1c)), fasting glucose, within-patient fasting glucose variability and body weight change were measured at 14 weeks.
Glycaemic control improved in both NPH (HbA(1c) = -0.2%, p < 0.05; fasting glucose -1.0 mmol/l, p < 0.0001) and glargine (HbA(1c) = -0.6%, p < 0.0001; fasting glucose -1.4 mmol/l, p < 0.0001) groups, including a reduction in fasting glucose variability (p < 0.01 for both). The incidence of total and nocturnal hypoglycaemia was reduced in both NPH and glargine groups. The incidence of major hypoglycaemia was low and did not change significantly during the follow-up period. Mean body weight was significantly reduced in the NPH (-0.7 kg, p < 0.01) and glargine (-0.5 kg, p < 0.05) groups.
These results indicate that in type 2 diabetes, transferring from other basal insulins to insulin detemir in combination with OADs was associated with improvements in glycaemic control, which were accompanied by a reduced risk of hypoglycaemia and a reduction in body weight.
本研究旨在评估地特胰岛素对先前接受中性精蛋白锌胰岛素(NPH组,n = 175)或甘精胰岛素(甘精胰岛素组,n = 118)联合口服降糖药(OADs)治疗的2型糖尿病患者的安全性和有效性。
患者转换为地特胰岛素治疗,同时OAD治疗方案和注射次数保持不变。在14周时测量严重药物不良反应的发生率,包括严重低血糖,以及糖化血红蛋白(HbA(1c))、空腹血糖、患者内空腹血糖变异性和体重变化。
NPH组(HbA(1c) = -0.2%,p < 0.05;空腹血糖 -1.0 mmol/l,p < 0.0001)和甘精胰岛素组(HbA(1c) = -0.6%,p < 0.0001;空腹血糖 -1.4 mmol/l,p < 0.0001)的血糖控制均得到改善,包括空腹血糖变异性降低(两组均p < 0.01)。NPH组和甘精胰岛素组的总体和夜间低血糖发生率均降低。严重低血糖的发生率较低,在随访期间无显著变化。NPH组(-0.7 kg,p < 0.01)和甘精胰岛素组(-0.5 kg,p < 0.05)的平均体重显著降低。
这些结果表明,在2型糖尿病中,从其他基础胰岛素转换为地特胰岛素联合OADs治疗与血糖控制改善相关,同时低血糖风险降低,体重减轻。