Sanofi gets CDSCO Panel nod to study Antidiabetic Drug Insulin Glargine and Lixisenatide Injection
New Delhi: The drug major Sanofi has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial in order to evaluate the safety and efficacy of a fixed ratio combination of Glargine 100 U/mL and Lixisenatide 33/50 mcg/mL in adults with type 2 diabetes who are suboptimally controlled on oral antihyperglycemic drugs and/or basal Insulin/GLP-1 RA (receptor agonist).
This came after the drug maker Sanofi presented the proposal to conduct a Phase IV clinical trial titled “Multicentre Phase IV single-arm clinical trial to evaluate the safety and efficacy of a fixed ratio combination of Glargine 100 U/mL and Lixisenatide 33/50 mcg/mL in adults with type 2 diabetes who are suboptimally controlled on oral antihyperglycemic drugs and/or basal Insulin/GLP-1 RA” vide Protocol No: LPS18016Version 1.0 dated 16.08.2023.
Insulin glargine is a long-acting, synthetic version of human insulin. Insulin glargine 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. It also stops the liver from producing more sugar.
Insulin glargine is a synthetic version of human insulin that is FDA-approved to treat adults and children with type 1 diabetes and adults with type 2 diabetes to improve and maintain glycemic control. Insulin glargine is a long-acting insulin injected once daily and provides a basal insulin level throughout the day.
Lixisenatide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying. Clinical trials demonstrate that lixisenatide is an effective add-on pharmacotherapy option to achieve goal HbA1c levels.
Lixisenatide injection is used to treat type 2 diabetes mellitus. Lixisenatide is used together with diet and exercise to help control your blood sugar. This medicine is a glucagon-like peptide-1 (GLP-1) receptor agonist. This medicine is available only with your doctor's prescription.
At the recent SEC meeting for Endocrinology and Metabolism held on 13th and 14th February 2023, the expert panel reviewed the proposal to conduct Phase IV clinical trial titled “Multicentre Phase IV single-arm clinical trial to evaluate the safety and efficacy of a fixed ratio combination of Glargine 100 U/mL and Lixisenatide 33/50 mcg/mL in adults with type 2 diabetes who are suboptimally controlled on oral antihyperglycemic drugs and/or basal Insulin/GLP-1 RA”.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase IV study with the following changes in protocol-
1. Patients on premixed and basal-bolus therapy should be excluded from the study
2. Wash-out period of 5 half-lives to be given to patients who are on DPP- 4 inhibitors.
Accordingly, the expert panel suggested that the firm should submit the revised protocol to CDSCO.
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