"Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
Primary Purpose
Diabetes Mellitus, Type 2, Weight Change, Body
Status
Recruiting
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Semaglutide Pen Injector
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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.
Sites / Locations
- Rehman Medical InstituteRecruiting
- Aga Khan University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
semaglutide
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Weight Changes in Obese People
use of semaglutide may help obese people in controlling their weight gain.
Full Information
NCT ID
NCT05249881
First Posted
February 9, 2022
Last Updated
August 3, 2022
Sponsor
Aga Khan University
Collaborators
Rehman Medical Institute - RMI
1. Study Identification
Unique Protocol Identification Number
NCT05249881
Brief Title
"Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
Official Title
"Efficacy of Once-weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
Rehman Medical Institute - RMI
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Weight Change, Body
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
semaglutide
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Semaglutide Pen Injector
Other Intervention Name(s)
Ozempic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in glycemic Index in Diabetes mellitus type-2 Patients
Description
Once weekly Semaglutide may result to remarkably change HbA1c level with in 3 months of use
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight Changes in Obese People
Description
use of semaglutide may help obese people in controlling their weight gain.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Tahir Ghaffar, MBBS, FCPS
Phone
+92-3339284987
Email
drtgktk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Fahim Ullah, MBBS, FCPS
Phone
03329142021
Email
drfaheemullah@gmail.com
Facility Information:
Facility Name
Rehman Medical Institute
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25100
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naseer Ahmed, PhD
Phone
0333-3382013
Email
dr.naseer99@gmail.com
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Enrolling by invitation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
"Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
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