Semaglutide 2•4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial

by Megha Desai · July 31, 2021

Type 2 Diabetes patients have multiple associated co-morbidities such as overweight or obesity and Diabetes medications often result in weight gain which puts additional pressure on the existing ailment.
Weight loss serves to be a great measure to reduce complications and enhance glycaemic control.
Among GLP-1 receptor agonists presently accessible for the treatment of diabetes, semaglutide 1.0 mg has shown the best weight reduction impact in patients with type 2 diabetes and is presently being examined at the higher portion of 2.4 mg for weight loss. Melanie Davies and colleagues conducted a study titled “Semaglutide 2•4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised,double-blind, double-dummy, placebo-controlled, phase 3 trial” and the summary has been given below:

Objectives

The study aims to assess the efficacy of a 2.4 mg dose of semaglutide in T2DM patients on weight loss.

Methods

A double blind, double dummy, placebo-controlled, phase 3 superiority study involving adults with a BMI of 27 kg/m2 and HBA1c: 7–10% having T2DM diagnosed 180 days before screening were employed.
The recruitment of patients was from 149 clinics spread across 12 countries and they were arbitrarily allotted (1:1:1) by means of an intuitive web-response framework and separated by background glucose-reducing medications and HBA1c to subcutaneous injection of semaglutide 2.4 mg or 1.0 mg or a similar placebo, once-weekly for a period of 68 weeks in addition to lifestyle modification. The major end points were weight reductions of 5 % in patients who were administered with a 2.4 mg dosage.

Findings

The study reflected improvements in body-weight, waist circumference, HbA1c, systolic blood pressure and physical functioning. Changes were also seen in lipid profile and inflammatory markers. UACR, Alanine aminotransferase and aspartate aminotransferase reported a decrease in comparison to placebo. The extent of weight loss achieved was greater on 2.4 mg of subcutaneous Semaglutide dosage.
Commonly reported events that were short-term included nausea, vomiting, diarrhoea and constipation. Discontinuations following gastrointestinal adverse events was low. The safety profile was consistent with the phase 2 study. Overall the study was conclusive of the finding of clinically meaningful weight loss.