Retinal examination be done at each visit: CDSCO Panel tells Alkem Lab on Semaglutide Injection Phase III CT study
New Delhi: Considering the bioequivalence study report of Semaglutide Injection 2 mg presented by the drug major Alkem Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the phase III clinical study of the proposed drug with the modification in the clinical trial (CT) protocol that retinal examination (fundoscopy) should be done at each visit.
This came after Alkem Laboratories presented the bioequivalence study report and phase III CT study protocol ALK37-SEM1, Version No. 03, dated 08.10.2024 in Type 2 Diabetes Mellitus for additional strength of Semaglutide Injection 2 mg {(8mg/3ml) (2.68mg/ml)} before the Committee.
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 receptor agonists. It mimics the GLP-1 hormone, released in the gut in response to eating.
Semaglutide improves the efficiency of incretin function by activating GLP-1 receptors. It acts by numerous mechanisms, like augmented insulin secretion (glucose-dependent), inhibition of glucagon release and suppressed hepatic gluconeogenesis, thereby reducing both fasting and postprandial glucose.
Semaglutide injection is used to treat type 2 diabetes. It is used together with diet and exercise to help control your blood sugar. This medicine is also used to lower the risk of heart attack, stroke, or death in patients with type 2 diabetes, obesity, and heart or blood vessel disease.
At the recent SEC meeting for Endocrinology and Metabolism held on 13th January 2025, the expert panel reviewed the bioequivalence study report and Phase III CT study Protocol ALK37-SEM1, Version No. 03, dated 08.10.2024 in Type 2 Diabetes Mellitus for additional strength of Semaglutide Injection 2 mg {(8mg/3ml) (2.68mg/ml)}.
After detailed deliberation, the committee considered the bioequivalence report and recommended the grant of permission for the Phase III CT study with the following change in the CT protocol.
Retinal examination (fundoscopy) should be done at each visit
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