Doubling the dose of Semaglutide (2.0 mg) more superior than the single dose of 1.0 mg in controlling HbA1c levels, suggests a study published in The Lancet: Diabetes and Endocrinology journal.
Semaglutide is similar to a natural hormone incretin that works works by causing insulin release in response to high blood sugarand decreasing the amount of sugar produced liver.
It is useful for controlling blood sugar with a proper diet and exercise program to in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.
Semaglutide is beneficial for treating type 2 diabetes. However, 20–30% of patients receiving semaglutide 1·0 mg are unable to reach the glycaemic treatment goals.
A study was conducted by Frías J et. al to examine the effectiveness and safety of semaglutide 2·0 mg versus 1·0 mg once-weekly in adults with uncontrolled type 2 diabetes on a stable dose of metformin with or without a sulfonylurea.
The researchers conducted a 40-week, randomized, active-controlled, parallel-group, double-blind, phase 3B trial (SUSTAIN FORTE). They included a total of 125 outpatient clinics in ten countries. All the participants were 18 years and above with poorly controlled type 2 diabetes (HbA1c 8·0–10·0%) with metformin and with or without sulfonylurea.
In total 1515 adults were assessed for eligibility, out of which 961 participants with a mean age of 58 years were included, between June 19, 2019, to November 28, 2019. Participants were randomly assigned to once-weekly semaglutide 2·0 mg group (n=462) (96%) and 471 (98%) in the semaglutide 1·0 mg group completed the trial.
The primary outcome was a change from baseline at week 40 in HbA1c and secondary outcome was bodyweight, evaluated through trial product estimand and treatment policy estimand strategies.
The results of the study are as follows:
· Mean baseline HbA1c was 8·9% and BMI was 34·6 kg/m.
· Mean change in HbA1c from baseline at week 40 was −2·2 percentage points with semaglutide 2·0 mg and −1·9 percentage points with semaglutide 1·0 mg and −2·1 percentage points with semaglutide 2·0 mg and −1·9 percentage points with semaglutide 1·0 mg.
· Mean change in body weight from baseline at week 40 was −6·9 kg with semaglutide 2·0 mg and −6·0 kg with semaglutide 1·0 mg and −6·4 kg with semaglutide 2·0 mg and −5·6 kg with semaglutide 1·0 mg. Gastrointestinal disorders were the most commonly reported adverse events; which were marginally more in the 2·0 mg group (163) than in the 1·0 mg group (148).
· Serious adverse events were similar between both the treatment groups. Three deaths were reported during the trial (one in the semaglutide 1·0 mg group and two in the semaglutide 2·0 mg group).
The researchers concluded that Semaglutide 2·0 mg was superior to 1·0 mg in reducing HbA1c, with additional bodyweight loss and a similar safety profile. This higher dose provides a treatment intensification option for patients with type 2 diabetes treated with semaglutide in need of additional glycaemic control.
Reference:
Efficacy and safety of once-weekly semaglutide 2·0 mg versus 1·0 mg in patients with type 2 diabetes (SUSTAIN FORTE): a double-blind, randomized, phase 3B trial by Frías J et. al published in the Lancet: Diabetes and Endocrinology journal.
DOI: https://doi.org/10.1016/S2213-8587(21)00174-1
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