Catrina Sergiu-Bogdan, Amadid Hanan, Braae Uffe C, Dereke Jonatan, Ekberg Neda Rajamand, Klanger Boris, Jansson Stefan
Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden.
Centrum for Diabetes, Academic Specialist Centrum, Stockholm, Sweden.
Diabetes Ther. 2024 Sep;15(9):2079-2095. doi: 10.1007/s13300-024-01614-6. Epub 2024 Jul 25.
The study was designed to assess outcomes with once-daily oral semaglutide in adults with type 2 diabetes (T2D) naïve to injectable glucose-lowering agents, in Swedish clinical practice.
In this non-interventional, multicentre study, participants initiated oral semaglutide and were followed for 34-44 weeks. The primary endpoint was glycated haemoglobin (HbA) change from baseline to end of study (EOS). Secondary endpoints included body weight (BW) change from baseline to EOS, proportion of participants achieving HbA < 7%, and proportion achieving both a HbA reduction ≥ 1% and BW reduction of ≥ 3% or ≥ 5%, at EOS. Participants completed Diabetes Treatment Satisfaction Questionnaires (DTSQ status/change) and a dosing conditions questionnaire.
A total of 187 participants (mean age 62.5 years) initiated oral semaglutide. Baseline mean HbA and BW were 7.8% (n = 177) and 96.9 kg (n = 165), respectively. Estimated mean changes in HbA and BW were - 0.88%-points (95% confidence interval [CI] - 1.01 to - 0.75; P < 0.0001) and - 4.72% (95% CI - 5.58 to - 3.86; P < 0.0001), respectively. At EOS, 64.6% of participants had HbA < 7%, and 22.9% achieved HbA reduction of ≥ 1% and BW reduction of ≥ 5%. DTSQ status and change scores improved by 1.44 (P = 0.0260) and 12.3 points (P < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 86.4% of participants. Most common adverse events (AEs) were gastrointestinal disorders; nine participants (4.8%) had serious AEs; one (0.5%) experienced severe hypoglycaemia.
In this real-world study population, we observed significant reductions in HbA and BW in people living with T2D when prescribed semaglutide tablets as part of routine clinical practice in Sweden, with improved treatment satisfaction among participants and no new safety concerns.
NCT04601753.
本研究旨在评估在瑞典临床实践中，对于初治的2型糖尿病（T2D）成人患者，每日一次口服司美格鲁肽的治疗效果。
在这项非干预性多中心研究中，参与者开始口服司美格鲁肽，并随访34 - 44周。主要终点是糖化血红蛋白（HbA）从基线到研究结束（EOS）的变化。次要终点包括从基线到EOS的体重（BW）变化、HbA＜7%的参与者比例，以及在EOS时HbA降低≥1%且体重降低≥3%或≥5%的参与者比例。参与者完成糖尿病治疗满意度问卷（DTSQ状态/变化）和给药条件问卷。
共有187名参与者（平均年龄62.5岁）开始口服司美格鲁肽。基线时HbA和BW的平均值分别为7.8%（n = 177）和96.9 kg（n = 165）。HbA和BW的估计平均变化分别为 - 0.88个百分点（95%置信区间[CI] - 1.01至 - 0.75；P＜0.0001）和 - 4.72%（95% CI - 5.58至 - 3.86；P＜0.0001）。在EOS时，64.6%的参与者HbA＜7%，22.9%的参与者HbA降低≥1%且体重降低≥5%。DTSQ状态和变化得分分别提高了1.44（P = 0.0260）和12.3分（P＜0.0001）。86.4%的参与者认为口服司美格鲁肽易于或非常易于服用。最常见的不良事件（AE）是胃肠道疾病；9名参与者（4.8%）发生严重AE；1名（0.5%）经历严重低血糖。
在这个真实世界的研究人群中，我们观察到在瑞典的常规临床实践中，将司美格鲁肽片剂作为T2D患者治疗的一部分时，患者的HbA和BW显著降低，参与者的治疗满意度提高，且没有新的安全问题。
NCT04601753
