Zydus Announces Completion of Phase III trials of Saroglitazar Magnesium in Type 2 Diabetes Mellitus

Zydus Announces Completion of Phase III trials of Saroglitazar Magnesium in Type 2 Diabetes Mellitus Ahmedabad, India, 02 Aug 2019 Zydus Cadila, an innovation -driven, global pharmaceutical company, announced that it has completed Phase 3 Clinical Trial in India of Saroglitazar Mg for treating Type 2 Diabetes. The trial was a multi-centric, randomized, double blind study to evaluate the safety and efficacy of 2mg and 4mg of Saroglitazar compared to Pioglitazone 45mg in patients with Type 2 D iabetes Mellitus. The Phase 3 trial enrolled 1140 subjects and studied the patients over a period of 56 weeks. [CTRI/2015/09/006203] The primary outcome of the trial was a change from baseline in glycosylated haemoglobin (HbA1c) for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg at 24 weeks. The study also measured glycosylated haemoglobin (HbA1c) and other secondary outcome measures including fasting plasma glucose, Triglyceride (TG) cholesterol, Low Density Lipoprotein (LDL) cholesterol, Very Low Density Lipoprotein (VLDL) cholesterol, High Density Lipoprotein (HDL) cholesterol, Total Cholesterol (TC) cholesterol, Non HDL cholesterol, Apolipoprotein (Apo) A1, Apo B between Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg at Week 12, Week 24, and Week 56. The Phase 3 trial has demonstrated efficacy and achieved statistical significance for its primary endpoint which was the change in mean HbA1c as compared to the baseline. No severe hypoglycaemia events were reported . Ther e was no weight gain or edema observed with Saroglitazar Mg. “Insulin resistance is the root cause of T ype 2 Diabetes Mellitus and the data from this trial reveals that Saroglitazar Mg, a next -generation Insulin Sensitizer without the ede ma and weight ga in side- effects, could emerge as a potent anti-diabetic agent for millions of patients suffering from Type -2 Diabetes.” said Pankaj R. Patel, Chairman, Zydus group. Saroglitazar Magnesium was launched in India during September 2013 under the brand name ‘Lipaglyn’, for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients with Type-2 diabetes not controlled by statins. About Zydus Research Centre The Zydus Research Centre has over 20 discovery programmes in the areas of cardio-metabolic disorders, pain, inflammation and oncology. Zydus has in-house capabilities to conduct discovery research from concept to IND-enabling pre-clinical development and human proof-of-concept clinical trials. About Zydus Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs over 23,000 people worldwide, including 1400 scientists engaged in R & D, and is dedicated to creating healthier communities globally. www.zyduscadila.com

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