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

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Getz Pharma
• Treatments: Metformin; Sitagliptin Phosphate

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