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Real-World Evidence of Biosynthetic Semaglutide in Pakistan: A Multicenter Observational Study on Efficacy, and Quality of Life.

Real world effectiveness of once weekly biosynthetic semaglutide in type 2 diabetes population: A multicenter prospective study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000610437
Enrollment
268
Registered
2025-06-12
Start date
2025-07-01
Completion date
2025-11-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will evaluate the safety and efficacy of biosynthetic semaglutide in patients with Type 2 Diabetes in a real-world clinical setting. We hypothesize that semaglutide will improve blood sugar levels (HbA1c) and lead to other health benefits, including reductions in weight, low-density lipoprotein (LDL), and triglycerides, as well as improved high-density lipoprotein (HDL). The study will include patients who provide informed consent and initiate semaglutide treatment as part of routine care. Data will be collected at multiple time points to assess the treatment's effectiveness and safety over a 28–38 week period.

Interventions

Participants enrolled in this study are individuals who have been prescribed semaglutide as part of their routine clinical care for type 2 diabetes by their treating physicians, independent of study participation. This study will assess these participants clinically while they continue their usual diabetes management, which may include oral antidiabetic medications, insulin, and semaglutide. No investigational use of semaglutide is involved, and its prescription is not contingent upon participat

Participants enrolled in this study are individuals who have been prescribed semaglutide as part of their routine clinical care for type 2 diabetes by their treating physicians, independent of study participation. This study will assess these participants clinically while they continue their usual diabetes management, which may include oral antidiabetic medications, insulin, and semaglutide. No investigational use of semaglutide is involved, and its prescription is not contingent upon participation in the study.. Semaglutide will be administered in doses of 0.25 mg, 0.5 mg, or 1.0 mg once weekly, as prescribed by the treating physician, in accordance with standard clinical guidelines and individual patient needs. The duration of semaglutide use will vary depending on each participant's clinical course, with a minimum follow-up of 30 weeks during the study period. Semaglutide will be administered as a subcutaneous injection. Participants will self-administer semaglutide after receiving training from their healthcare provider on proper injection techniques. Adherence to semaglutide will be monitored through a combination of self-reported diaries, medication refill records, and clinical follow-up visits. The treatment protocol is defined as per the Amercian Diabetes Association Guidieline Reference, Care D. Standards of care in diabetes—2023. Diabetes care. 2023;46:S1-267. "8. Obesity and Weight Management for the Prevention and Treatment of Type 2 Diabetes: Standards of Care in Diabetes–2025." Diabetes Care 48, no. Supplement_1 (2025): S167-S180.

Sponsors

Ferozsons Laboratories
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

- Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) The decision to initiate treatment with commercially available biosynthetic semaglutide has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study Male or female, age 18 years or older at the time of signing informed consent Diagnosed with type 2 diabetes at least 12 weeks prior to inclusion Available and documented haemoglobin A1c (HbA1c) value equal to or below 12 weeks prior to initiation of semaglutide treatment

Exclusion criteria

- Previous participation in this study. Participation is defined as having given informed consent in this study Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Treatment with any investigational drug within 90 days prior to enrolment into the study Hypersensitivity to semaglutide or to any of the excipients

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 30, 2026