Eli Lilly Gets CDSCO Panel Nod To Conduct Phase IV CT of Lyumjev
New Delhi: The drug major Eli Lilly has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase IV study of Insulin Lispro Ultra-rapid (UR) injection 100 units/mL solution for injection titled as “a 26-week, multicenter, open-label, single-arm, Phase 4 study to assess the safety of Lyumjev in adult patients with type 2 diabetes mellitus in India”
This came after the firm presented their proposal to conduct a Phase IV study of Insulin Lispro Ultra-rapid (UR) injection 100 units/mL solution for injection titled “a 26-week, multicenter, open-label, single-arm, Phase 4 study to assess the safety of Lyumjev in adult patients with type 2 diabetes mellitus in India” vide protocol No. I8B- MC-ITTA (b) dated 01.05.2023.
Lyumjev is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
Lyumjev is a novel formulation of insulin lispro. It speeds the absorption of insulin into the bloodstream and reduces A1C levels, and was approved by the FDA in June 2020. As a rapid-acting mealtime insulin, Lyumjev helps control blood sugar levels after meals in adults with diabetes, similar to how natural insulin works after meals in people without diabetes.
Insulin lispro injection products are a short-acting, manmade version of human insulin. Insulin lispro injection products work by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy.
Insulin lispro is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours.
Insulin lispro is a modified form of fast-acting insulin used to control hyperglycemia in diabetes mellitus. Insulin lispro is a rapid-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes.
At the recent SEC meeting for Endocrinology and Metabolism held on 22nd and 23rd August 2023, the expert panel reviewed the proposal presented by Eli Lilly for conducting a Phase IV study of Insulin Lispro Ultra-rapid (UR) injection 100 units/mL solution for injection.
After detailed deliberation, the committee recommended approval of the proposed protocol to conduct the Phase IV clinical trial as presented by the firm.
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