Impact of Dapagliflozin as Add-on Therapy on Glycemic Status and Quality of Life in Type 2 Diabetic Patients
Dapagliflozin
Treatment Study
Summary
Study start date: May 1, 2022
Actual date on which the first participant was enrolled.The study aims to evaluate the effects of adding a medication called Dapagliflozin to the existing treatment regimen of adults with Type 2 Diabetes Mellitus (T2DM). Participants are adults aged 18 to 70 who are already taking a combination of oral diabetes drugs, including sulfonylurea, metformin, and gliptin, but still have high blood sugar levels. The goal is to see if Dapagliflozin can help lower blood sugar levels and improve quality of life for these patients. This research is important because finding effective ways to manage high blood sugar in people with T2DM can help prevent complications and improve long-term health outcomes. In this study, participants take a 5mg dose of Dapagliflozin once daily for 16 weeks. The study monitors blood sugar levels and any changes in the patient's quality of life during this period. The dosage of sulfonylurea, one of the existing medications, may be reduced if there are concerns about low blood sugar. Throughout the study, researchers track adherence to the medication and any side effects, such as genitourinary infections. Participation ends for those who cannot stick to the medication schedule or experience significant side effects. Out of the initial 45 participants, 40 complete the study, providing valuable data on the effectiveness and safety of Dapagliflozin as an additional treatment for T2DM.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * elevated glycosylated hemoglobin A1c (HbA1c) \[7%-12.0%\] at the time of enrollment Exclusion Criteria: \-
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location