- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Sun Pharma Laboratories Gets CDSCO Panel Nod To study Antidiabetic FDC Drug
New Delhi: The drug major Sun Pharma Laboratories 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 of the fixed dose combination (FDC) antidiabetic drug Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin plus Glimepiride plus Extended Release Metformin Hydrochloride Tablets (10 mg + 1 mg + 1000 mg) and (10 mg + 2 mg + 1000 mg) Tablets.
This came after Sun Pharma Laboratories presented the Phase IV clinical trial protocol before the committee in light of the condition mentioned in permission in Form CT-23 dated 10.10.2023.
Dapagliflozin plus Glimepiride plus Metformin is a combination of three antidiabetic medications.
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. Dapagliflozin inhibits the sodium-glucose cotransporter 2 (SGLT2), which is primarily located in the proximal tubule of the nephron.SGLT2 facilitates 90% of glucose reabsorption in the kidneys, and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
Glimepiride is a sulfonylurea drug used to treat type 2 diabetes mellitus. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (KATP channels) and causing depolarization of the beta cells.
Metformin is a biguanide antihyperglycemic agent and a first-line pharmacotherapy used in the management of type II diabetes.
Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer," leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels.
Dapagliflozin plus glimepiride plus metformin is used in the treatment of type 2 diabetes mellitus.
At the recent SEC meeting for endocrinology and metabolism held on June 11, 2024, the expert panel reviewed the Phase IV clinical trial protocol of the antidiabetic FDC drug Dapagliflozin Propanediol Monohydrate plus Glimepiride plus Metformin Hydrochloride Tablets.
After detailed deliberation, the committee recommended a grant of permission to conduct the Phase IV clinical trial.
In view of the above, the expert panel suggested that the firm submit the Phase IV clinical trial report to CDSCO.
Also Read:Zydus Life Science Gets CDSCO Panel Nod To Manufacture and Market Anti-cancer Drug Nelarabine
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751