Madsbad S, Kilhovd B, Lager I, Mustajoki P, Dejgaard A
Hvidovre Hospital, Copenhagen, Denmark, Aker Sykehus, Oslo, Norway.
Diabet Med. 2001 May;18(5):395-401. doi: 10.1046/j.1464-5491.2001.00490.x.
To evaluate the long-term effectiveness and safety of repaglinide, a novel prandial glucose regulator, in comparison with glipizide in the treatment of patients with Type 2 diabetes.
Diet or tablet-treated patients with Type 2 diabetes (n = 256; age 40-75 years, body mass index (BMI) 20-35 kg/m2, HbA1c 4.2-12.8%), without signs of severe microvascular or macrovascular complications, were included in this double-blind, multicentre, parallel-group comparative trial. Patients were randomized at a 2:1 ratio to repaglinide, 1-4 mg at mealtimes, or glipizide, 5-15 mg daily.
Changes in fasting blood glucose (FBG) and HbA1c during the 12 months of treatment showed a significant difference in favour of repaglinide. In oral hypoglycaemic agents (OHA)-naive patients, HbA1c decreased in the repaglinide and glipizide groups by 1.5% and 0.3%, respectively (P < 0.05 between groups). Fasting blood glucose decreased in the repaglinide group by 2.4 mmol/l and increased in the glipizide group by 1.0 mmol/l (P < 0.05 between groups). In the study population as a whole, repaglinide was able to maintain glycaemic control (HbA1c level) during the 1-year study period, whereas control deteriorated significantly with glipizide. Change in HbA1c from baseline was significantly better with repaglinide than with glipizide after 12 months (P < 0.05). In addition, FBG deteriorated significantly in the glipizide group compared with the repaglinide group (P < 0.05). No patients in either group experienced a major hypoglycaemic event; the number of patients experiencing minor hypoglycaemia was similar in the repaglinide and glipizide groups (15% and 19%, respectively).
Repaglinide, given as a prandial glucose regulator, is shown to be an effective and safe treatment of patients with Type 2 diabetes, and is better than glipizide in controlling HbA1c and FBG levels, overall, and in OHA-naive patients.
比较新型餐时血糖调节剂瑞格列奈与格列吡嗪治疗2型糖尿病患者的长期有效性和安全性。
本双盲、多中心、平行组对照试验纳入了256例2型糖尿病患者(年龄40 - 75岁,体重指数(BMI)20 - 35 kg/m²,糖化血红蛋白(HbA1c)4.2 - 12.8%),这些患者采用饮食或片剂治疗,且无严重微血管或大血管并发症迹象。患者按2:1的比例随机分为瑞格列奈组(餐时服用1 - 4 mg)或格列吡嗪组(每日服用5 - 15 mg)。
治疗12个月期间,空腹血糖(FBG)和HbA1c的变化显示瑞格列奈组有显著优势。在未使用过口服降糖药(OHA)的患者中,瑞格列奈组和格列吡嗪组的HbA1c分别降低了1.5%和0.3%(两组间P < 0.05)。瑞格列奈组空腹血糖降低了2.4 mmol/l,而格列吡嗪组升高了1.0 mmol/l(两组间P < 0.05)。在整个研究人群中,瑞格列奈在1年研究期间能够维持血糖控制(HbA1c水平),而格列吡嗪组的血糖控制明显恶化。12个月后,瑞格列奈组HbA1c从基线的变化显著优于格列吡嗪组(P < 0.05)。此外,格列吡嗪组的空腹血糖与瑞格列奈组相比显著恶化(P < 0.05)。两组均无患者发生严重低血糖事件;发生轻微低血糖的患者数量在瑞格列奈组和格列吡嗪组中相似(分别为15%和19%)。
作为餐时血糖调节剂的瑞格列奈被证明是治疗2型糖尿病患者的一种有效且安全的药物,总体上以及在未使用过OHA的患者中,其在控制HbA1c和FBG水平方面优于格列吡嗪。