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

Aga Khan University

Status and phase: Enrolling; Early Phase 1

Conditions: Diabetes Mellitus, Type 2; Weight Change, Body

Treatments: Drug: Semaglutide Pen Injector

Study type: Interventional

Funder types: Other

Identifiers

NCT05249881

07125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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300 participants in 1 patient group

semaglutide

Other group

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

Treatment:

Drug: Semaglutide Pen Injector