Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, Colorado, USA.
Diabetes Technol Ther. 2024 Jun;26(6):367-374. doi: 10.1089/dia.2024.0050. Epub 2024 Apr 18.
Most patients with type 1 diabetes (T1D) in the United States are overweight (OW) or obese (OB), contributing to insulin resistance and suboptimal glucose control. The primary Food and Drug Administration-approved treatment for T1D is insulin, which may adversely affect weight. Tirzepatide is approved for managing type 2 diabetes, improves glucose control, facilitates weight loss, and improves cardiovascular disease outcomes. We assessed the use of tirzepatide in OW/OB subjects with T1D. This was a retrospective single-center real-world study in 62 OW/OB adult patients with T1D who were prescribed tirzepatide (treated group) and followed for 1 year. At least 3 months of use of tirzepatide was one of the inclusion criteria. Based on the inclusion criteria, this study represents 62 patients out of 184 prescribed tirzepatide. The control group included 37 OW/OB patients with T1D (computer frequency matched by age, duration of diabetes, gender, body mass index (BMI), and glucose control) who were not using any other weight-loss medications during the same period. The mean (±standard deviation [SD]) dose of weekly tirzepatide at 3 months was 5.6 ± 1.9 mg that increased to 9.7 ± 3.3 mg at 1 year. The gender, mean baseline age, duration of diabetes, and glycosylated hemoglobin (HbA1c) were similar in the two groups, whereas BMI and weight were higher in the treated group. There were significantly larger declines in BMI and weight in the treated group than in controls across all time points among those in whom data were available. HbA1c decreased in the treated group as early as 3 months and was sustained through a 1-year follow-up (-0.67% at 1 year). As expected, insulin dose decreased at 3 months and throughout the study period. There were no reported hospitalizations from severe hypoglycemia or diabetic ketoacidosis. The mean glucose, time-in-range, time-above-range, SD, and coefficient of variation (continuous glucose monitoring metrics) significantly improved in the treated group. In this pilot (off label) study, we conclude that tirzepatide facilitated an average 18.5% weight loss (>46 pounds) and improved glucose control in OW/OB patients with T1D at 1 year. For safe use of tirzepatide in patients with T1D, we strongly recommend a large prospective randomized control trial in OW/OB patients with T1D.
大多数美国 1 型糖尿病（T1D）患者超重（OW）或肥胖（OB），这导致胰岛素抵抗和血糖控制不佳。美国食品和药物管理局批准的 T1D 的主要治疗方法是胰岛素，而胰岛素可能会对体重产生不利影响。替西帕肽获批用于治疗 2 型糖尿病，可改善血糖控制，促进体重减轻，并改善心血管疾病结局。我们评估了替西帕肽在 OW/OB 伴 T1D 患者中的应用。这是一项在 62 名 OW/OB 成年 T1D 患者中进行的回顾性单中心真实世界研究，这些患者接受了替西帕肽治疗（治疗组）并随访了 1 年。至少使用替西帕肽 3 个月是纳入标准之一。根据纳入标准，本研究代表了同期处方替西帕肽的 184 名患者中的 62 名。对照组包括 37 名 OW/OB 伴 T1D 患者（按年龄、糖尿病病程、性别、体重指数（BMI）和血糖控制进行计算机频率匹配），同期未使用任何其他减肥药。在 3 个月时每周替西帕肽的平均（±标准差[SD]）剂量为 5.6±1.9mg，在 1 年时增加至 9.7±3.3mg。两组的性别、平均基线年龄、糖尿病病程和糖化血红蛋白（HbA1c）相似，而治疗组的 BMI 和体重较高。在有数据可查的患者中，治疗组在所有时间点的 BMI 和体重均显著下降，对照组则没有。治疗组的 HbA1c 在 3 个月时就开始下降，并在 1 年的随访中持续下降（1 年时下降 0.67%）。正如预期的那样，胰岛素剂量在 3 个月时下降，并在整个研究期间持续下降。没有因严重低血糖或糖尿病酮症酸中毒而住院的报告。治疗组的平均血糖、达标时间、超标时间、SD 和变异系数（连续血糖监测指标）显著改善。在这项初步（超适应证）研究中，我们得出结论，替西帕肽可使 OW/OB 伴 T1D 患者平均减重 18.5%（>46 磅），并在 1 年内改善血糖控制。为了在 T1D 患者中安全使用替西帕肽，我们强烈建议在 OW/OB 伴 T1D 患者中进行大型前瞻性随机对照试验。
