Efficacy and safety of once-weekly Efpeglenatide vs. Placebo as monotherapy in patients with type 2 diabetes (AMPLITUDE-M)
Efpeglenatide is being subcutaneously administered once per week as a long-acting GLP-1 receptor agonist. Frias JP and colleagues conducted a study under the title “Efficacy and safety of once-weekly Efpeglenatide vs. Placebo as monotherapy in patients with type 2 diabetes (AMPLITUDE-M)”. The summary of the study is as given below:
Objective:
To assess the efficacy and safety of Efpeglenatide in people with T2D, inadequately controlled with diet and exercise alone.
Method:
It is a double-blind, placebo-controlled, 30+26-week phase 3 study. T2D patients were randomly assigned to receive 2 mg, 4 mg, and 6 mg or PBO. The main outcome was a change in HbA1c from baseline. Secondary outcomes include BW, other parameters of glycaemic control, and safety.
Findings:
The study reports that all doses of Efpeglenatide lead to a greater reduction in HbA1c as compare to PBO. Additionally, BW was significantly reduced in the Efpeglenatide group. While only one patient experienced a single episode of severe hypoglycemia, others have well-tolerated Efpeglenatide with few reporting mild to moderate gastrointestinal complaints.
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