ANZCTR - Registration

Registration number

ACTRN12625000610437

Ethics application status

Approved

Date submitted

5/01/2025

Date registered

12/06/2025

Date last updated

12/06/2025

Date data sharing statement initially provided

12/06/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes Type 2

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Observational

Description of intervention(s) / exposure

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.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in Glycated Hemoglobin A1c (HbA1c)

Timepoint [1]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The fingure pricking test is advised to patient to conduct at home every day at any time convenient and record the reading in the Monitoring log book. However on the day of clinical visit for follow up at 0 week, 12 week and between 28-38 weeks the clinical staff will again conduct the on site fingure prick test to record the blood glucose reading for the day.

Primary outcome [2]

Change in HbA1c

Timepoint [2]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The venous blood will be collected on the baseline visit and after 3 months of the treatment initiation(12 week) and then at the end of the study between 28-38 week. This sample collected will be sent to laboratory for the assessment of HbA1c.

Secondary outcome [1]

Change in body weight

Timepoint [1]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. Weight will be measured on the baseline visit at week 0 and then at the end of the study which will be between week 28-38. This measurement will be taken by the trained staff at the clinic site.

Secondary outcome [2]

Change in body weight (%)

Timepoint [2]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. Weight will be measured on the baseline visit at week 0 and then at the end of the study which will be between week 28-38. This measurement will be taken by the trained staff at the clinic site.

Secondary outcome [3]

HbA1c level below 8.0%

Timepoint [3]

Baseline (upto 12 weeks prior Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness to treatment initiation (Week 0) to end of the study (week 28-38). The venous blood will be collected on the baseline visit and after 3 months of the treatment initiation(12 week) and then at the end of the study between 28-38 week. This sample collected will be sent to laboratory for the assessment of HbA1c. Later participants proportion will be calucated that achieved 8.0% or below HbA1c after the completion of study period.

Secondary outcome [4]

HbA1c level below 7.5%

Timepoint [4]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The venous blood will be collected on the baseline visit and after 3 months of the treatment initiation(12 week) and then at the end of the study between 28-38 week. This sample collected will be sent to laboratory for the assessment of HbA1c. Later participants proportion will be calucated that achieved 7.5% or below HbA1c after the completion of study period.

Secondary outcome [5]

Any change in HbA1c of 1.0% point or more

Timepoint [5]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The venous blood will be collected on the baseline visit and after 3 months of the treatment initiation(12 week) and then at the end of the study between 28-38 week. This sample collected will be sent to laboratory for the assessment of HbA1c. Later participants proportion will be calucated that had a change of 1.0% HbA1c after the completion of study period.

Secondary outcome [6]

Any change in weight of 3.0% or more

Timepoint [6]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. Weight will be measured on the baseline visit at week 0 and then at the end of the study which will be between week 28-38. This measurement will be taken by the trained staff at the clinic site. The number of participants who have achieved 3.0% or more weight loss.

Secondary outcome [7]

Any change in weight of 5.0% or more

Timepoint [7]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. Follow-Up Period: Weight will be measured on the baseline visit at week 0 and then at the end of the study which will be between week 28-38. This measurement will be taken by the trained staff at the clinic site. The number of participants who have achieved 5.0% or more weight loss.

Secondary outcome [8]

Any change in HbA1c of 1.0% point or more and any change in weight of 3% or more. This is a composite endpoint.

Timepoint [8]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. This measurement will be taken by the trained staff at the clinic site. The number of participants who have achieved 3.0% or more weight loss. The venous blood will be collected on the baseline visit and after 3 months of the treatment initiation(12 week) and then at the end of the study between 28-38 week. A venous blood sample will be used and later Number of participants who had a change in HbA1c of 1.0% point or more.

Secondary outcome [9]

Patient Reported Severe or documented hypoglycemia (Yes/No)

Timepoint [9]

Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The review of the medical record will be done at 12 weeks and between 28 and 38 weeks to assess the hypoglycemia.

Secondary outcome [10]

Change in score for Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) (absolute treatment satisfaction): Total treatment satisfaction

Timepoint [10]

Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The treatment satisfaction will be assessed at the baseline week 0 and at the end of the study between weeks 28 and 38.

Secondary outcome [11]

Change in score for Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) (relative treatment satisfaction): Total treatment satisfaction

Timepoint [11]

Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The questionnaire will be asked after the completion of the study period between week 28 and 38. This will be to check the change in diabetes treatment satisfaction

Secondary outcome [12]

Change in score for Short Form (SF)-36 v2: Physical summary component

Timepoint [12]

Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The quality of life Physical Summary Components will be assessed at the baseline week 0 and at the end of the study, between 28 and 38 weeks.

Secondary outcome [13]

Change in score for SF-36 v2: Mental summary component

Timepoint [13]

Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The quality of life The mental summary component will be assessed at the baseline week 0 and at the end of the study, between 28 and 38 weeks.

Secondary outcome [14]

Patient completed the study under treatment with semaglutide (yes/no)

Timepoint [14]

Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. (week 28 to 38) This will be collected from the medical record at the end of study between 28 and 38 weeks.

Secondary outcome [15]

Change in Low Density Lipoprotein

Timepoint [15]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The venous blood will be collected for the laboratory assessment at the baseline week 0 and between weeks 28 and 38.

Secondary outcome [16]

Change in High Density Lipoprotein

Timepoint [16]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The venous blood will be collected for the laboratory assessment at the baseline week 0 and between weeks 28 and 38.

Secondary outcome [17]

Change in triglyceride levels

Timepoint [17]

Baseline: Defined as up to 12 weeks prior to treatment initiation (Week 0). This includes the collection of demographic data, clinical history, and relevant baseline measurements. Treatment Initiation (Week 0): The date participants begin semaglutide administration as part of routine clinical care. Follow-Up Period: Spanning from Week 0 to the end of the study, which occurs between Week 28 and Week 38 following treatment initiation. This period includes scheduled assessments to monitor clinical outcomes and treatment effectiveness. The venous blood will be collected for the laboratory assessment at the baseline week 0 and between weeks 28 and 38.

Eligibility

Key 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

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key 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

Study design

Statistical methods / analysis

Descriptive Statistics: We will describe patient characteristics at semaglutide initiation using mean ± SD, median, range for continuous variables, and proportions for categorical variables.
Analysis Sets: The Full Analysis Set (FAS) will include all patients who provide consent and start semaglutide. The Effectiveness Analysis Set (EAS) will include those who complete the study and receive semaglutide at EOS.
Primary Analysis: We will use ANCOVA to analyze primary and secondary endpoints based on the EAS, adjusting for baseline changes and excluding patients with missing EOS data.
Sensitivity Analyses: Sensitivity analyses will use mixed models for repeated measurements (MMRM) on the FAS to assess the impact of missing data.
Subgroup and Post Hoc Analyses: We will perform subgroup analyses based on pre-initiation treatments and post hoc analyses on BP, lipids, baseline HbA1c, and BMI using adjusted ANCOVA.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2025

Actual

Date of last participant enrolment

Anticipated

30/11/2025

Actual

Date of last data collection

Anticipated

31/05/2026

Actual

Sample size

Target

268

Accrual to date

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Ferozsons Laboratories

Country [1]

Pakistan

Primary sponsor type

Commercial sector/Industry

Name

Ferozsons Laboratories

Country

Pakistan

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NorthWest General Hospital & Research Center

Ethics committee address [1]

Institutional Review Board for Ethics in Human Research Department of Pharmacy Practice Faculty of Pharmacy, Bosan Rd, Bahauddin Zakariya University, Multan, Punjab 60000, Pakistan

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

23/12/2024

Approval date [1]

29/04/2025

Ethics approval number [1]

IRB&EC/2025-GH/0228

Summary

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.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Muhammad Daoud Butt

Address

Muhammad Daoud Butt, Umar Diabetes Foundation, Malak shafait plaza, Mauza Mahal kot, Hathial, Main Murree Rd, Barakahu, Islamabad, Islamabad Capital Territory 44000, Pakistan

Country

Pakistan

Phone

+923308488833

Email

[email protected]

Contact person for public queries

Name

Muhammad Daoud Butt

Address

Muhammad Daoud Butt, Umar Diabetes Foundation, Malak shafait plaza, Mauza Mahal kot, Hathial, Main Murree Rd, Barakahu, Islamabad, Islamabad Capital Territory 44000, Pakistan

Country

Pakistan

Phone

+923308488833

Email

[email protected]

Contact person for scientific queries

Name

Muhammad Daoud Butt

Address

Muhammad Daoud Butt, Umar Diabetes Foundation, Malak shafait plaza, Mauza Mahal kot, Hathial, Main Murree Rd, Barakahu, Islamabad, Islamabad Capital Territory 44000, Pakistan

Country

Pakistan

Phone

+923308488833

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically