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

Sponsor

Aga Khan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05249881

Collaborator

Rehman Medical Institute - RMI (Other)

300

Enrollment

Locations

Arm

8.7

Anticipated Duration (Months)

150

Patients Per Site

17.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Weight Change, Body	Drug: Semaglutide Pen Injector	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in glycemic Index in Diabetes mellitus type-2 Patients [3 months]
Once weekly Semaglutide may result to remarkably change HbA1c level with in 3 months of use

Secondary Outcome Measures

Weight Changes in Obese People [3 months]
use of semaglutide may help obese people in controlling their weight gain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehman Medical Institute	Peshawar	KPK	Pakistan	25100
2	Aga Khan University	Karachi	Sindh	Pakistan	74800

Sponsors and Collaborators

Aga Khan University
Rehman Medical Institute - RMI

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NASEER AHMED, Assistant Professor, Aga Khan University

ClinicalTrials.gov Identifier:

NCT05249881

Other Study ID Numbers:

07125

First Posted:

Feb 22, 2022

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Body Weight Changes

Study Results

No Results Posted as of Aug 5, 2022