Glenmark gets CDSCO panel nod to study antidiabetic drug Lobeglitazone Sulfate
New Delhi: In a significant development, drug firm Glenmark has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to conduct a study of antidiabetic medication from the thiazolidinedione class of drug, Lobeglitazone sulfate.
This nod came with the condition that the study should be a 2-arm double-blind 16 week study of Lobeglitazone vs. Pioglitazone followed by 3-arms 12 weeks of study of Pioglitazone vs. Lobeglitazone vs. the FDC.
The expert panel also highlighted that the results of the 16-week double-blind trial be forwarded to CDSCO for further consideration by the committee. The continuation of the study to the third arm part of the study will be evaluated based on the outcomes of the abovementioned study.
This came after the pharmaceutical major Glenmark presented a bioequivalence (BE) study report and revised clinical trial protocol before the committee, in accordance with the earlier SEC recommendation dated 16.12.2020.
Lobeglitazone is an antidiabetic medication from the thiazolidinedione class of drugs, which primarily acts as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells.
Lobeglitazone has been shown to reduce blood sugar levels, lower haemoglobin A1C (HbA1C) levels, and improve lipid and liver profiles, by activating PPAR-gamma and promoting the binding of insulin to fat cells.
The Ministry of Food and Drug Safety (South Korea) approved lobeglitazone in 2013, and it is being monitored by postmarketing monitoring until 2019. However, this drug is not approved by either the Food and Drug Administration (USA), Health Canada, or by the European Medicines Agency for use in the management of diabetes.
Earlier, the Medical Dialogues Team had reported that Glenmark had presented a proposal for a Phase III clinical trial protocol along with the BE Study protocol for Lobeglitazone Sulphate Tablets 0.5 mg, which was deliberated by the committee at the 87th Subject Expert Committee (SEC) meeting for Endocrinology & Metabolism held on 15.06.2021 and 16.06.2021 at CDSCO.
Following a thorough review, in response, the committee gave its nod to conduct the Bioequivalence Study (BE study) of said formulation, based on the condition that the firm submit the BE Study report along with the revised Clinical Trial (CT) protocol with the inclusion criteria of the cardiology parameters.
In continuation, at the recent SEC meeting for Endocrinology & Metabolism, the expert panel thoroughly examined the bioequivalence (BE) study report and revised clinical trial protocol presented by Glenmark to study Lobeglitazone sulfate.
After detailed deliberation, the committee recommended the grant of permission to conduct the study with the following condition:
1. The study should be 2-arm double blind 16 week study of Lobeglitazone vs. Pioglitazone followed by 3-arms 12 weeks study of Pioglitazone vs. Lobeglitazone vs. the FDC.
2. The results of the 16 weeks double blind study should be submitted to CDSCO for further review by the committee. Based on the results of the said study, continuation of the study to the 3rd arm part of the study will be considered.