Impact of Treviamet® & Treviamet XR® on quality of life besides glycemic control in type 2 DM patients

• Published in: BMC endocrine disorders 2023-11, Vol.23 (1), p.1-244, Article 244
• Main Authors: Khan, Asima, Kanpurwala, Muhammad Adnan, Khan, Riasat Ali, Mahmudi, Najum F, Lohano, Verumal, Ahmed, Shakeel, Khan, Majid, Uddin, Fareed, Ali, Syed Mohammad, Saghir, Maliha, Baqar Abidi, Syed Hussain, Kamal, Jahanzeb
• Format: Article
• Language: English
• Subjects: Adverse events; Analysis; Antidiabetics; Blood pressure; Body weight; Care and treatment; Dextrose; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes therapy; Diarrhea; FDA approval; Gender; Glucagon; Glucose; Glycosylated hemoglobin; Hypoglycemia; Insulin; Metformin; Nausea; Patient satisfaction; Patients; Quality of life; Questionnaires; Regression analysis; Sitagliptin; Type 2 diabetes; Type 2 Diabetes Mellitus; Variables; Variance analysis
• ISSN: 1472-6823; 1472-6823
• DOI: 10.1186/s12902-023-01492-2

Background 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[R] & Treviamet XR[R] (Sitagliptin with Metformin) in routine care. Methods It was a prospective, open-label, non-randomized clinical trial including T2DM patients uncontrolled on Metformin therapy. All patients received Treviamet[R] & Treviamet XR[R] 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. Results 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). Conclusion Treviamet[R] & Treviamet XR[R] significantly improved glycemic control (HbA1c levels) and QoL in T2DM patients without serious adverse events. Trial registration ClinicalTrials.gov identifier (NCT05167513), Date of registration: December 22, 2021. Keywords: Quality of life, Type 2 Diabetes Mellitus, Sitagliptin, Metformin