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

NCT05249881 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: 07125
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2; Weight Change, Body

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Weight Changes in Obese People

  3 months

Study Arms (1)

semaglutide

OTHER

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

Interventions

Semaglutide Pen Injector DRUG

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.

Also known as: Ozempic

semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead
• Rehman Medical Institute - RMI: collaborator

Study Sites (2)

Rehman Medical Institute

Peshawar, KPK, 25100, Pakistan

RECRUITING

Aga Khan University

Karachi, Sindh, 74800, Pakistan

ENROLLING BY INVITATION

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Body Weight Changes

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Tahir Ghaffar, MBBS, FCPS

CONTACT

+92-3339284987; drtgktk@gmail.com

Dr. Fahim Ullah, MBBS, FCPS

CONTACT

03329142021; drfaheemullah@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 22, 2022
• Study Start: March 10, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)