Zydus completes phase III trials of Diabetes drug in India: Company

Zydus Cadila on Friday said it has completed phase III clinical trial of Saroglitazar Mg, used for treating type 2 Diabetes, in India.

"The trial was a multi-centric, randomised, double blind study to evaluate the safety and efficacy of 2mg and 4mg of Saroglitazar compared to Pioglitazone 45mg in patients with type 2 Diabetes Mellitus.

"The phase 3 trial enrolled 1,140 subjects and studied the patients over a period of 56 weeks," Zydus Cadila said in a statement.

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.

 

"Insulin resistance is the root cause of type 2 Diabetes Mellitus and the data from this trial reveals that Saroglitazar Mg, a next-generation Insulin Sensitizer without the edema and weight gain side effects, could emerge as a potent anti-diabetic agent for millions of patients suffering from type 2 Diabetes," said Zydus group Chairman Pankaj R Patel.

Shares of Cadila Healthcare, the listed entity of the group, were trading 0.82 per cent higher at Rs 228.10 apiece on BSE.