Public Health Department, Baqai Institute of Diabetology and Endocrinology, Karachi, Pakistan.
Department of Physiology, Karachi Institute of Medical Sciences affiliated with NUMS, Karachi, Pakistan.
BMC Endocr Disord. 2023 Nov 8;23(1):244. doi: 10.1186/s12902-023-01492-2.
Maintaining the quality of life is the main objective of managing type 2 diabetes (T2DM) (QoL). Since it is a key factor in patient motivation and adherence, treatment-related QoL has always been considered when choosing glucose-lowering medicines. The objective of the study was to evaluate the quality of life besides glycemic control among type 2 diabetes mellitus patients receiving Treviamet® & Treviamet XR® (Sitagliptin with Metformin) in routine care.
It was a prospective, open-label, non-randomized clinical trial including T2DM patients uncontrolled on Metformin therapy. All patients received Treviamet® & Treviamet XR® for six months. Sequential changes in QoL, fasting plasma glucose, HbA1c, body weight, and blood pressure were monitored from baseline to 3 consecutive follow-up visits. The frequency of adverse events (AEs) was also noted throughout the study.
A total of 504 patients were screened; 188 completed all three follow-ups. The mean QoL score significantly declined from 57.09% at baseline to 33.64% at the 3rd follow-up visit (p < 0.01). Moreover, a significant decline in mean HbA1c and FPG levels was observed from baseline to 3rd follow-up visit (p < 0.01). Minor adverse events were observed, including abdominal discomfort, nausea, flatulence, and indigestion. Gender, HbA1c, diarrhea, and abdominal discomfort were significant predictors of a patient's QoL, as revealed by the Linear Regression Model (R2 = 0.265, F(16, 99) = 2.231).
Treviamet® & Treviamet XR® significantly improved glycemic control (HbA1c levels) and QoL in T2DM patients without serious adverse events.
ClinicalTrials.gov identifier (NCT05167513), Date of registration: December 22, 2021.
维持生活质量是管理 2 型糖尿病（T2DM）（QoL）的主要目标。由于它是患者动机和依从性的关键因素，因此在选择降糖药物时，一直考虑与治疗相关的 QoL。本研究的目的是评估接受二甲双胍联合治疗的 2 型糖尿病患者在常规护理中除血糖控制外的生活质量。
这是一项前瞻性、开放标签、非随机临床试验，纳入了二甲双胍治疗未控制的 2 型糖尿病患者。所有患者均接受二甲双胍联合 Treviamet®&Treviamet XR®（西格列汀与二甲双胍）治疗 6 个月。从基线到 3 次连续随访监测生活质量、空腹血糖、HbA1c、体重和血压的变化。整个研究过程中还记录了不良事件（AE）的发生频率。
共筛选了 504 例患者，188 例完成了所有 3 次随访。生活质量评分从基线时的 57.09%显著下降至第 3 次随访时的 33.64%（p<0.01）。此外，从基线到第 3 次随访时，HbA1c 和 FPG 水平也显著下降（p<0.01）。观察到轻微的不良事件，包括腹部不适、恶心、腹胀和消化不良。性别、HbA1c、腹泻和腹部不适是患者生活质量的显著预测因素，线性回归模型（R2=0.265，F(16, 99)=2.231）揭示了这一点。
二甲双胍联合 Treviamet®&Treviamet XR®在不发生严重不良事件的情况下显著改善了 2 型糖尿病患者的血糖控制（HbA1c 水平）和生活质量。
ClinicalTrials.gov 标识符（NCT05167513），注册日期：2021 年 12 月 22 日。
