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

What Was Tested

This registered early phase 1 trial tested Semaglutide.

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.

It had 1 arm (groups): semaglutide (other).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 300 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Both male and female Type 2 Diabetic patients with age ≥18 years. Patients with BMI ≥ 30.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: patients with type 1 diabetes mellitus; patients with gestational diabetes mellitus; patient already on another glp 1 analogue.

How the Study Was Run

Design: sequential and open-label.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2022-03-10 with completion listed for 2022-12.

It ran at 2 sites in Pakistan (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in glycemic Index in Diabetes mellitus type-2 Patients (time frame: 3 months).

It also tracked 1 secondary outcome, for example Weight Changes in Obese People.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Semaglutide in 300 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.