Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Diabetes Metab Res Rev. 2012 Mar;28(3):236-40. doi: 10.1002/dmrr.1292.
Oral anti-diabetes drugs plus basal insulin (OAD + insulin) therapy in patients with newly diagnosed type 2 diabetes might improve β-cell function and result in extended glycaemic remission. This randomised trial compared the effect on β-cell function and diabetes remission rate between oral drug alone or with addition of basal insulin.
One hundred and twenty-nine patients, aged 35-50 years, were enrolled between June 2005 and June 2009. For initial correction of hyperglycaemia, patients with fasting plasma glucose ≥9.0 mmol/L and HbA(1c) ≥ 9.0%, were randomly assigned to therapy with oral drugs + insulin or oral drugs alone. Treatment was stopped after normoglycaemia was maintained for 3 months. Patients were then followed-up with diet and physical exercise. Blood glucose, HbA(1c) and insulin were measured prior to treatment and at 1-year follow-up.
More patients achieved target glycaemic control in the oral drugs + insulin group [98.3% (58 of 59)] in less time [(10.4 ± 2.5) days] than those in the oral drug group [95.7% (67 of 70) and (12.4 ± 3.4) days]. At 1-year follow-up, more patients maintained target glycaemia without any drugs in the oral drug + insulin group than in the oral drug group [37.9% (22 of 58) vs 20.9% (14 of 67)]. Both treatments improved homeostasis model assessment-β (HOMA-β) and homeostasis model assessment-insulin resistance (HOMA-IR) significantly. They had similar effects on insulin resistance [lg(HOMA-IR): (0.50 ± 0.09) vs (0.48 ± 0.09), p = 0.23]. However, oral drugs + insulin could recover β-cell function much more than OAD alone could [lg(HOMA-β): (2.17 ± 0.14) vs (2.11 ± 0.13), p = 0.03].
In newly diagnosed type 2 diabetes, therapy with oral drugs + insulin has had favourable outcomes on recovery and maintenance of β-cell function and protracted glycaemic remission compared with treatment with oral drugs alone.
对于新诊断的 2 型糖尿病患者，联合使用口服降糖药和基础胰岛素（OAD+胰岛素）治疗可能会改善β细胞功能并延长血糖缓解时间。本随机试验比较了单独使用口服药物或添加基础胰岛素对β细胞功能和糖尿病缓解率的影响。
129 名年龄在 35-50 岁的患者于 2005 年 6 月至 2009 年 6 月期间入组。对于空腹血糖≥9.0mmol/L 和 HbA1c≥9.0%的患者，初始纠正高血糖时，随机分为口服药物+胰岛素或单独口服药物治疗。在血糖正常维持 3 个月后停止治疗。然后，患者接受饮食和运动锻炼随访。在治疗前和 1 年随访时测量血糖、HbA1c 和胰岛素。
更多患者在口服药物+胰岛素组中达到目标血糖控制[98.3%（58/59）]，且用时更少[（10.4±2.5）天]，而在口服药物组中[95.7%（67/70）和（12.4±3.4）天]。在 1 年随访时，口服药物+胰岛素组中更多患者在不使用任何药物的情况下维持目标血糖[37.9%（22/58）vs 20.9%（14/67）]。两种治疗均显著改善了稳态模型评估-β（HOMA-β）和稳态模型评估胰岛素抵抗（HOMA-IR）。它们对胰岛素抵抗的影响相似[lg（HOMA-IR）：（0.50±0.09）vs （0.48±0.09），p=0.23]。然而，口服药物+胰岛素治疗比单独使用口服药物治疗更能恢复β细胞功能[lg（HOMA-β）：（2.17±0.14）vs （2.11±0.13），p=0.03]。
在新诊断的 2 型糖尿病中，与单独使用口服药物治疗相比，联合使用口服药物和基础胰岛素治疗在恢复和维持β细胞功能以及延长血糖缓解方面具有更好的效果。
