"Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
- Sponsor
- Aga Khan University
- Study ID
- NCT05249881
- Phase
- EARLY_PHASE1
- Status
- Unknown
Conditions
- Diabetes Mellitus, Type 2
- Weight Change, Body
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Semaglutide Pen Injector — DRUGAll Diabetes mellitus type2 patients fulfilling the inclusion criteria, will receive 0.25mg Semaglutide injection per week and after two weeks dosage will be escalated to 0.5 mg/week for next 10 weeks.
Study Details
A prospective interventional trial for 9 months will be carried out on 300 type-2 diabetes mellitus volunteer patients who are above 18-year-old and participants will be selected through consecutive sampling and will be evaluated on the basis of glycemic index and history of patients. Selected parameters will be measured at baseline and after the 12 weeks of therapy. Statistical analysis will be carried out by SPSS, ANOVA, and t-test. From this experimental design, we are expecting improvement in the management of glycemic index, reduction in systolic and diastolic blood pressure, and reduction in weight GLP-1 naive patients.
Key Dates
- Start date
- Mar 10, 2022
- Status verified
- Aug 2022
- Primary completion
- Dec 31, 2022
- Completion
- Dec 31, 2022
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Other: semaglutidesemaglutide is an anti-diabetic medication used for the treatment of type 2 diabetes and long-term weight management. Semaglutide acts like human glucagon-like peptide-1 in that it increases insulin secretion, thereby increasing sugar metabolism
Primary Outcome Measure
Change in glycemic Index in Diabetes mellitus type-2 Patients [ Time Frame: 3 months ]
Central Contacts
- Dr. Tahir Ghaffar, MBBS, FCPS+92-3339284987
- Dr. Fahim Ullah, MBBS, FCPS03329142021
Related Studies
- An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)Enrolling By Invitation · Novo Nordisk A/S · Morgantown, West Virginia
- Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)Recruiting · The University of Texas Health Science Center at San Antonio · San Antonio, Texas
- POWERMOM, A Healthy Pregnancy Research CommunityRecruiting · Scripps Translational Science Institute · La Jolla, California
- Tau PET Imaging in the Northern Manhattan Study of Metabolism and Mind.PHASE2 · Enrolling By Invitation · Columbia University · New York, New York