Hopitaux Universitaires de Strasbourg, France.
Diabetes Obes Metab. 2009 Apr;11(4):379-86. doi: 10.1111/j.1463-1326.2008.00980.x. Epub 2008 Dec 14.
To determine whether earlier administration of insulin glargine (glargine) vs. the intensification of lifestyle management (LM) improves glycaemic control in type 2 diabetes patients with A1c 7-8% treated with oral therapy.
TULIP [Testing the Usefulness of gLargine when Initiated Promptly in type 2 diabetes mellitus (T2DM)] was a 9-month, 12-visit, open-label, multinational, multicentre, randomized study to evaluate starting glargine or intensifying LM in T2DM patients aged 40-75 years, body mass index (BMI) 24-35 kg/m2 and A1c 7-8%, treated with maximum doses of metformin and sulphonylurea for > or = 2 years. Glargine was injected once daily (evening) and titrated to fasting blood glucose 0.7-1.0 g/l. In the LM arm, dietary and physical activity counselling recommended stable weight for people with BMI < 27 kg/m2 or weight loss of 3 kg for patients with BMI > or = 27 kg/m2. A total of 215 patients were randomized to glargine (n = 106) or LM (n = 109). The primary objective was patients achieving A1c < 7% at endpoint. Secondary endpoints included changes in A1c, in fasting plasma glucose (FPG), body weight and hypoglycaemia incidence.
Two hundred and eleven (52.6% male) patients were randomized and treated; mean (+/- s.d.) age 60.7 +/- 7.9 years, weight 84.5 +/- 13.1 kg, BMI 29.9 +/- 3.5 kg/m2 and A1c 7.6 +/- 0.4%. More patients reached A1c < 7% (66 vs. 38%; p < 0.0001) or < 6.5% (34 vs. 11%; p = 0.0001) with glargine vs. LM. The change in FPG from baseline to study endpoint was significantly greater in the glargine vs. the LM arm (-0.50 +/- 0.47 vs. -0.05 +/- 0.39 g/l respectively; p < 0.0001). Compared with the glargine group, the LM group showed a decrease in weight (+0.9 +/- 2.9 vs. -2.5 +/- 3.2 kg; p < 0.0001), as well as the expected lower symptomatic hypoglycaemia (55.3 vs. 25.0%; p < 0.0001) and nocturnal hypoglycaemia (20.4 vs. 5.6%; p = 0.0016). No significant changes were observed from baseline to study endpoint in any of the lipid parameters tested.
In patients with T2DM with A1c 7-8%, who were previously treated by conventional LM and OAD therapy, adding glargine resulted in greater improvements in glycaemic control vs. intensifying LM.
在接受口服药物治疗且糖化血红蛋白（A1c）为 7-8%的 2 型糖尿病患者中，比较甘精胰岛素（glargine）早期给药与生活方式强化管理（LM）对血糖控制的改善作用。
TULIP[在 2 型糖尿病中即刻起始甘精胰岛素治疗的效用性测试（T2DM）]是一项 9 个月、12 次访视、开放性、多国、多中心、随机研究，评估了在年龄 40-75 岁、体重指数（BMI）24-35kg/m2 和 A1c 7-8%、接受最大剂量二甲双胍和磺脲类药物治疗>2 年的 2 型糖尿病患者中，起始甘精胰岛素或强化 LM 的效果。甘精胰岛素每晚 1 次（傍晚）注射，并滴定至空腹血糖 0.7-1.0g/l。在 LM 组中，建议对 BMI<27kg/m2 的患者保持稳定体重，对 BMI≥27kg/m2 的患者减轻 3kg 体重。共有 215 名患者被随机分配至甘精胰岛素组（n=106）或 LM 组（n=109）。主要终点是患者在终末点时达到 A1c<7%。次要终点包括 A1c、空腹血浆葡萄糖（FPG）、体重和低血糖发生率的变化。
211 名（52.6%为男性）患者被随机分配并接受治疗；平均（+/-标准差）年龄 60.7+/-7.9 岁，体重 84.5+/-13.1kg，BMI 29.9+/-3.5kg/m2，A1c 7.6+/-0.4%。与 LM 组相比，更多的患者达到 A1c<7%（66 vs. 38%；p<0.0001）或<6.5%（34 vs. 11%；p=0.0001）。与 LM 组相比，甘精胰岛素组的 FPG 从基线到研究终点的变化明显更大（-0.50+/-0.47 vs. -0.05+/-0.39g/l；p<0.0001）。与甘精胰岛素组相比，LM 组体重减轻（+0.9+/-2.9 vs. -2.5+/-3.2kg；p<0.0001），并出现预期的低血糖（55.3 vs. 25.0%；p<0.0001）和夜间低血糖（20.4 vs. 5.6%；p=0.0016）发生率降低。在研究终点时，所有测试的血脂参数均未观察到从基线到研究终点的任何显著变化。
在接受常规 LM 和 OAD 治疗且 A1c 为 7-8%的 2 型糖尿病患者中，与强化 LM 相比，添加甘精胰岛素可使血糖控制得到更大改善。
