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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Weight Change, Body
• Intervention / Treatment: Drug: Semaglutide Pen Injector

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Dr. Fahim Ullah, MBBS, FCPS; Phone Number: 03329142021; Email: drfaheemullah@gmail.com
• Study Contact Backup: Name: Dr. Tahir Ghaffar, MBBS, FCPS; Phone Number: +92-3339284987; Email: drtgktk@gmail.com

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25100
      • Recruiting
      • Rehman Medical Institute
      • Contact: Naseer Ahmed, PhD; Phone Number: 0333-3382013; Email: dr.naseer99@gmail.com
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Enrolling by invitation
      • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: semaglutide; semaglutide 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	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.; Other Names: Ozempic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Changes in Obese People	use of semaglutide may help obese people in controlling their weight gain.	3 months

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: Rehman Medical Institute - RMI

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Diabetes Mellitus, Type 2; Body Weight Changes
• Other Study ID Numbers: 07125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes