Eli Lilly Gets CDSCO Nod To Study Anti-diabetic Dulaglutide

New Delhi: Pharmaceutical major, Eli Lilly has got the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) approval to study the Phase IV study of anti-diabetic drug Dulaglutide as per the study protocol.

This came after the firm presented the protocol for conduct of Phase IV study titled “A 24-week multicenter, open-label, single-arm study to evaluate safety in patients with type 2 diabetes mellitus in India treated with Dulaglutide”. Protocol no.H9X-IN-GBGR, H9X-IN-GBGR(a)dated 16 Sep 2022.

Dulaglutide, marketed by Eli Lilly as Trulicity, is a once-weekly subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonist designed using recombinant DNA technology; it has been approved as an adjunct therapy to diet and exercise in the management of 2 diabetes (T2DM). Dulaglutide was initially approved by the FDA in 2014, and in February 2020 was approved for use in patients with T2DM and multiple cardiovascular risk factors for the prevention of cardiovascular events.

Dulaglutide activates the GLP-1 receptor found in pancreatic beta cells, increasing intracellular cyclic AMP (cAMP) in beta cells, leading to insulin release and subsequent reduction of blood glucose concentrations. Additionally, dulaglutide decreases glucagon secretion and slows gastric emptying.

At the recent SEC meeting for Endocrinology and Metabolism held on 19th and 20th October 2022, the expert panel reviewed the protocol presented by the firm to conduct Phase IV study of the anti-diabetic drug Dulaglutide in order to evaluate safety in patients with type 2 diabetes mellitus.
After detailed deliberation, the committee recommended the grant of permission to conduct the study as per presented protocol.:

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