Velojic-Golubovic M, Mikic D, Pesic M, Dimic D, Radenkovic S, Antic S
Clinic of Endocrinology, Clinical Center, Nis, Serbia.
J Endocrinol Invest. 2009 Jan;32(1):23-7. doi: 10.1007/BF03345673.
This 3-month study compared the effect on overall glycemic control of adding biphasic insulin aspart 30 (BIAsp30) and premixed human insulin 30/70 (BHI30) to metformin (met) in insulin-naïve, obese patients (30 males/20 females) with Type 2 diabetes (T2DM). MATERIAL/SUBJECTS: At baseline, patients had a mean age of 58.7 yr, glycated hemoglobin (HbA1c) 9.5%, and body mass index 34+/-2 kg/m2. Patients received either twice-daily BIAsp30 (no.=20) or twice-daily BHI30 (no.=30), and continued to receive maximal doses (2000 mg) of met for the duration of the study, but sulphonylurea oral antidiabetic drugs were discontinued. Primary efficacy endpoint was the change in HbA1c in both groups at study end. Safety endpoints included hypoglycemic episodes and weight gain.
Both groups reduced HbA1c by end of trial: BIAsp30 + met by 2.5% [2.16-2.86%; 95% confidence interval (CI)]; BHI30 + met by 1.18% (0.98- 1.39%; 95% CI), giving a significantly better HbA1c reduction with BIAsp30 + met (1.33%; p<0.05). Post-prandial plasma glucose decreased in both groups, by 6.38 mmol/l in patients treated with BIAsp30 + met, and by 4.34 mmol/l in those treated with BHI30 + met (p<0.05). Fasting plasma glucose also decreased in both groups, with a slightly larger decrease seen in BIAsp30 patients than in BHI30 patients (7.36 mmol/l at end of study vs 7.82 mmol/l; p=ns). Subjects treated with BIAsp30 gained less weight than those receiving BHI30 (0.3+/-0.1 kg vs 1.2+/-0.4 kg). There was no significant difference in the frequency or number of hypoglycemic episodes between groups.
Adding BIAsp30 to met in obese patients with T2DM results in better glycemic control and less weight gain than adding BHI30.
这项为期3个月的研究比较了在初治的肥胖2型糖尿病（T2DM）患者（30名男性/20名女性）中，加用门冬胰岛素30（BIAsp30）和预混人胰岛素30/70（BHI30）至二甲双胍（met）对总体血糖控制的影响。材料/受试者：基线时，患者平均年龄58.7岁，糖化血红蛋白（HbA1c）9.5%，体重指数34±2kg/m²。患者接受每日两次的BIAsp30（n=20）或每日两次的BHI30（n=30），并在研究期间继续接受最大剂量（2000mg）的met，但停用磺酰脲类口服降糖药。主要疗效终点是两组研究结束时HbA1c的变化。安全终点包括低血糖事件和体重增加。
试验结束时两组均降低了HbA1c：BIAsp30+met组降低2.5%[2.16-2.86%；95%置信区间（CI）]；BHI30+met组降低1.18%（0.98-1.39%；95%CI），BIAsp30+met组HbA1c降低明显更好（1.33%；p<0.05）。两组餐后血糖均下降，BIAsp30+met治疗的患者下降6.38mmol/l，BHI30+met治疗的患者下降4.34mmol/l（p<0.05）。两组空腹血糖也均下降，BIAsp30组患者下降幅度略大于BHI30组患者（研究结束时分别为7.36mmol/l和7.82mmol/l；p=无统计学意义）。接受BIAsp30治疗的受试者体重增加少于接受BHI30治疗的受试者（0.3±0.1kg对1.2±0.4kg）。两组间低血糖事件的频率或次数无显著差异。
在肥胖T2DM患者中，加用BIAsp30至met比加用BHI30能更好地控制血糖且体重增加更少。
