Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients

Overview

Scarcity of local patients' quality of life data assessing diabetes treatment led us design a protocol to assess improvement in the quality of life of patients with Type II Diabetes mellitus. Quality of life measures are designed to enable patients' perspectives on the impact of health \& healthcare interventions on their lives to be assessed \& taken into account in clinical decision making \& research. Its an open label experimental study where participants are assessed for quality of life impact over 6 months duration on Metformin + Sitagliptin therapy. Their safety and efficacy profiles will also be monitored

Study Objective: To assess the changes in quality of life (QOL) in patients with type 2 diabetes mellitus receiving sitagliptin plus metformin therapy in routine care. Study design: Open label, prospective, multicenter, experimental study. Sample size: The sample size is 157. To overcome loss to follow-ups, total n=300 will be recruited where each site will enroll 30 patients. Number of Site: There will be 10 sites. Duration of study: 12 months (data lock point will be the completion of 6 months of follow-up from the time of last patient's enrollment date) Study Treatment: Dose of Sitagliptin + Metformin (Treviamet® pharmaceutical brand used locally) : For Sitagliptin + metformin: \[50mg+500mg, 50mg+850mg, 50mg+1000mg\] For Sitagliptin + metformin Extended Release (XR): \[50mg+500mg, 50mg+1000mg\]. Safety Assessment: Patient will be monitored for Hypoglycemia, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion Other adverse events and serious adverse events. Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy. Study outcomes: Primary (QoL outcomes): Diabetes Quality of Life assessment using DQOL-13 questionnaire. Secondary (Safety and Efficacy outcomes): Frequency of adverse events and serious adverse events during the course of study follow-up. Change from baseline in HbA1c % and FBS (mg/dl) to the last-observation on treatment. Ethical consideration: The ethical approval of study is taken from Pakistan Medical Association. The study will be conducted in compliance with the protocol, good clinical practices (GCP), the ethical principles that have their origin in the Declaration of Helsinki and the applicable regulatory requirements.