Abdul-Ghani Muhammad, Migahid Osama, Megahed Ayman, DeFronzo Ralph A, Zirie Mahmoud, Jayyousi Amin
Diabetes Research, Academic Health System, Hamad General Hospital, Doha, Qatar.
Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229.
J Clin Endocrinol Metab. 2017 Jul 1;102(7):2162-2170. doi: 10.1210/jc.2016-3423.
To examine the efficacy and safety of combination therapy with exenatide plus pioglitazone vs basal/bolus insulin in patients with poorly controlled type 2 diabetes mellitus (T2DM) with very high hemoglobin A1c (HbA1c) (>10%) receiving sulfonylurea plus metformin and with a long duration of disease.
Participants (n = 101) in the Qatar Study with very poor glycemic control (HbA1c >10%) and a long duration of diabetes (10.9 years) receiving maximum/near-maximum doses of sulfonylurea plus metformin were randomly assigned to receive pioglitazone plus weekly exenatide (combination therapy), or basal plus prandial insulin (insulin therapy), to maintain HbA1c <7.0%.
Baseline HbA1c was 11.5% ± 0.2% and 11.2% ± 0.2% (P = not significant) in combination therapy and insulin therapy groups, respectively. At 6 months, combination therapy caused a robust decrease in HbA1c to 6.7% ± 0.1% (∆ = -4.8%) compared with 7.4% ± 0.1% (∆ = -3.8%) in subjects receiving insulin therapy. Combination therapy was effective in lowering the HbA1c independent of sex, ethnicity, or body mass index. Subjects in the insulin therapy group experienced significantly greater weight gain and a 2.5-fold higher rate of hypoglycemia compared with patients receiving combination therapy.
Exenatide/pioglitazone combination therapy is an effective and safe therapeutic option in patients with poorly controlled T2DM receiving metformin plus sulfonylurea with very high HbA1c (>10%).
在接受磺脲类药物加二甲双胍治疗且病程较长、糖化血红蛋白（HbA1c）水平非常高（>10%）、血糖控制不佳的2型糖尿病（T2DM）患者中，比较艾塞那肽联合吡格列酮与基础/餐时胰岛素联合治疗的疗效和安全性。
卡塔尔研究中的参与者（n = 101）血糖控制极差（HbA1c >10%）且糖尿病病程较长（10.9年），正在接受最大剂量/接近最大剂量的磺脲类药物加二甲双胍治疗，被随机分配接受吡格列酮加每周一次的艾塞那肽（联合治疗）或基础胰岛素加餐时胰岛素（胰岛素治疗），以维持HbA1c <7.0%。
联合治疗组和胰岛素治疗组的基线HbA1c分别为11.5%±0.2%和11.2%±0.2%（P =无显著差异）。6个月时，联合治疗使HbA1c显著降低至6.7%±0.1%（变化量= -4.8%），而接受胰岛素治疗的受试者为7.4%±0.1%（变化量= -3.8%）。联合治疗降低HbA1c的效果不受性别、种族或体重指数的影响。与接受联合治疗的患者相比，胰岛素治疗组的受试者体重增加明显更多，低血糖发生率高出2.5倍。
对于接受二甲双胍加磺脲类药物治疗且HbA1c水平非常高（>10%）、血糖控制不佳的T2DM患者，艾塞那肽/吡格列酮联合治疗是一种有效且安全的治疗选择。
