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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Quality of Life, Type 2 Diabetes, Metformin+Sitagliptin

Intervention / Treatment
-----------------
* Drug: Metformin / Sitagliptin Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with Type 2 Diabetes mellitus between 18 to 65 years HbA1C 7% - 10% who can give informed consent. Patient uncontrolled on metformin and lifestyle modification from at least 3 months or who are metformin resistant Exclusion Criteria: type 1 diabetes ≥1 episode of Diabetic Ketoacidosis and/or hyperosmolar hyperglycemic state, ≥1 episode of severe hypoglycaemia, Pregnant or lactating women, Pancreatitis, any serious complications or hypersensitivity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uncontrolled Diabetes with Metformin or Metformin resistant<br> | Drug: Metformin / Sitagliptin Oral Tablet<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Quality of Life assessment using DQOL-13 questionnaire | Satisfaction (6 questions) Impact (4 questions) Worry (3 questions) Scoring from 1 to 5 for worst to best quality at each question (low score means poor quality) Assessment at enrollment and follow ups (at 1st, 3rd and 6th months) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events and serious adverse events during the course of study follow-up |  | 6 months | 
| Change from baseline in HbA1c % and fasting blood sugar FBS (mg/dl) to the last-observation on treatment |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life, Type 2 Diabetes mellitus, Sitagliptin, Metformin