Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients
Condition: Quality of Life; Type 2 Diabetes; Metformin+Sitagliptin
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Metformin / Sitagliptin Oral Tablet
Intervention type(s): Drug
Intervention description(s): Metformin and sitagliptin are oral diabetes medicines that help control blood sugar levels.
Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating.
Metformin and sitagliptin is a combination medicine that is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. metformin and sitagliptin is not for treating type 1 diabetes.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of life; Type 2 Diabetes mellitus; Sitagliptin; Metformin