Karlander S G, Gutniak M K, Efendic S
Department of Endocrinology, Karolinska Hospital, Stockholm, Sweden.
Diabetes Care. 1991 Nov;14(11):963-7. doi: 10.2337/diacare.14.11.963.
To compare the long-term effect of combined treatment with insulin and glyburide versus insulin alone on serum lipid levels in non-insulin-dependent diabetic (NIDDM) patients with secondary failure to sulfonylurea therapy.
The study was a randomized double-blind placebo-controlled parallel trial with a duration of 325 days. The study was conducted at a referral-based endocrinology clinic. Subjects were a sequential sample of 20 patients with NIDDM with failure to respond to glyburide treatment after at least 1 yr of adequate glucose control with this therapy. The patients were randomized to treatment with insulin and glyburide (IG) or insulin and placebo (IP). Insulin was given twice daily to all patients as a mixture of NPH and regular insulins in dosages aiming at optimal glucose control. Glyburide or placebo was taken before breakfast (7 mg) and dinner (3.5 mg).
Mean HbA1c decreased from 11.1% (range 9.8-12.9%) before insulin to 9.1% (range 6.8-11.4%) on day 325 (P less than 0.001) in IG patients and from 10.3% (range 8.4-13.3%) to 9.0% (range 6.3-11.8%) (P less than 0.05) in IP patients. In both groups, there was an increase in high-density lipoprotein cholesterol of approximately 20% lasting throughout the study (P less than 0.01). During the first 83 days of the study, there was a decrease in serum cholesterol (P less than 0.01) and serum triglycerides (P less than 0.05) in both groups. All changes in lipid variables were comparable in magnitude and duration in both treatment with insulin and glyburide in NIDDM patients with secondary sulfonylurea failure improves lipid metabolism to a similar degree as insulin therapy alone.
比较胰岛素与格列本脲联合治疗和单纯胰岛素治疗对磺脲类药物治疗继发性失效的非胰岛素依赖型糖尿病（NIDDM）患者血脂水平的长期影响。
本研究为随机双盲安慰剂对照平行试验，为期325天。研究在一家基于转诊的内分泌诊所进行。受试者为连续选取的20例NIDDM患者，这些患者在使用格列本脲进行至少1年的充分血糖控制治疗后无反应。患者被随机分为胰岛素与格列本脲治疗组（IG）或胰岛素与安慰剂治疗组（IP）。所有患者均每日两次给予胰岛素，为中效胰岛素（NPH）和普通胰岛素的混合制剂，剂量旨在实现最佳血糖控制。格列本脲或安慰剂在早餐前（7mg）和晚餐前（3.5mg）服用。
IG组患者的平均糖化血红蛋白（HbA1c）从胰岛素治疗前的11.1%（范围9.8 - 12.9%）降至第325天的9.1%（范围6.8 - 11.4%）（P < 0.001），IP组患者从10.3%（范围8.4 - 13.3%）降至9.0%（范围6.3 - 11.8%）（P < 0.05）。在两组中，高密度脂蛋白胆固醇均增加了约20%，且在整个研究期间持续存在（P < 0.01）。在研究的前83天，两组的血清胆固醇（P < 0.01）和血清甘油三酯（P < 0.05）均有所下降。在磺脲类药物继发性失效的NIDDM患者中，胰岛素与格列本脲联合治疗和单纯胰岛素治疗在脂质变量方面的所有变化在幅度和持续时间上具有可比性，改善脂质代谢的程度相似。
