"Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

"Efficacy of Once-weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249881
• Other study ID #: 07125
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 10, 2022
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Aga Khan University
• Contact: Dr. Tahir Ghaffar, MBBS, FCPS
• Phone: +92-3339284987
• Email: drtgktk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Patients will be recruited from all the 12 centers included in the trial across Pakistan and data will be electronically transferred to the main center. All GLP-1 naive patients fulfilling the inclusion criteria will be recruited after informed written consent and started on Semaglutide injection 0.25mg for 2 weeks and will be escalated to 0.5 mg for the next 10 weeks. Socio-Demographic Data and health vitals including height, weight, BMI, baseline HbA1c, FBS and RBS will be recorded in preset Performa. All those who agree to participate will be given structured education on diet and exercise and those willing to comply will be recruited. A research assistant will be recruited and trained to teach the injection technique and discuss the adverse effects of Semaglutide to the participants. Patients taking DPP-4 inhibitors will be switched to GLP-1 analogue and only a single drug change in the form of adding Semaglutide will be done at the time. Semaglutide injection technique will be explained to the patient and one injection at a time will be provided to the patient to ensure compliance and avoid bias in the study. Patients will be asked to revisit after 4 weeks with the used injection device. After completion of 3 months of treatment vitals including height, weight, BMI, baseline HbA1c, FBS and RBS will be recorded in preset Performa.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Both male and female Type 2 Diabetic patients with age =18 years.
• Patients with HbA1c = 7.5 % - = 10.0%
• Patients with BMI = 30

Exclusion Criteria:

• Patients with Type 1 Diabetes Mellitus
• Patients with Gestational Diabetes Mellitus.
• Patients with Chronic Renal Failure with eGFR of = 30ml/min
• Patient already on another GLP 1 analogue
• The patient stopped any GLP1 analogue treatment less than 3 months back.
• Patients with history of chronic pancreatitis or pancreatic cancer.

Related Conditions & MeSH terms

• Body Weight Changes
• Diabetes Mellitus, Type 2
• Weight Change, Body

Intervention

Drug:
• Semaglutide Pen Injector
All 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.

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh
Pakistan	Rehman Medical Institute	Peshawar	KPK

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	Rehman Medical Institute - RMI

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycemic Index in Diabetes mellitus type-2 Patients	Once weekly Semaglutide may result to remarkably change HbA1c level with in 3 months of use	3 months
Secondary	Weight Changes in Obese People	use of semaglutide may help obese people in controlling their weight gain.	3 months