Dr Reddy's Laboratories Gets CDSCO Panel Nod To Study Semaglutide in Type 2 Diabetes Mellitus
New Delhi: Responding to the proposal presented by Dr. Reddy's Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to conduct a phase III clinical trial to evaluate the efficacy, safety, and tolerability of oral Semaglutide Tablets of Dr. Reddy’s Laboratories compared with RYBELSUS (Semaglutide) Tablets in adult patients with inadequately controlled Type 2 Diabetes Mellitus.
In addition to this, the expert panel suggested revising the protocol of the proposed drug. This came after the firm presented the proposal to conduct a Phase III clinical trial titled “A Randomized, Multicentric, Double-Blind, Active-Controlled, Parallel Group, Phase III Non-Inferiority Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral Semaglutide Tablets of Dr. Reddy’s Laboratories Pvt. Ltd Compared with RYBELSUS (Semaglutide) Tablets in Adult Patients with Inadequately Controlled Type 2 Diabetes Mellitus” vide Protocol no. DRL-IND-NDA28-SEM/2024,Version 1.0 dated 15 Oct 2024, along with the results of the bioequivalence (BE) study conducted by the firm in India.
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. It mimics the GLP-1 hormone, released in the gut in response to eating.
Semaglutide is a GLP-1 agonist that works by reducing appetite, delaying gastric emptying, increasing insulin release, and lowering the amount of glucagon released. Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity.
At the recent SEC meeting for endocrinology and metabolism held on 29th January 2025, the expert panel reviewed the proposal to conduct a Phase III clinical trial titled “A Randomized, Multicentric, Double-Blind, Active-Controlled, Parallel Group, Phase III Non-Inferiority Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral Semaglutide Tablets of Dr. Reddy’s Laboratories Pvt. Ltd Compared with RYBELSUS (Semaglutide) Tablets in Adult Patients with Inadequately Controlled Type 2 Diabetes Mellitus.”
After detailed deliberation, the committee recommended the approval to conduct the study with the following changes in the protocol:
1. Calcitonin limit in the inclusion criteria should be less than 100
2. BMI lower cutoff in inclusion criteria should be ≥23 kg/m² at screening
3. Diabetes insipidus should be removed in exclusion criteria.
4. Unstable retinopathy or maculopathy should be clearly defined in the exclusion criteria
5. Urine albumin and creatinine ratio should be part of the follow-up assessment.
6. Clinical trial sites should be geographically distributed and should include government sites.
Accordingly, the expert panel suggested that the revised protocol should be submitted to CDSCO for further evaluation.
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