StockMarketWire.com - AstraZeneca said its oral treatment to aid type-2 diabetic patients to manage blood glucose levels had received regulatory approval from the US Food and Drug Administration.
The US Food and Drug Administration (FDA) had approved Qternmet XR - a once-daily, oral medicine compromised of dapagliflozin, saxagliptin and metformin - extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes, the company said.
The approval was based on two Phase III trials, which evaluated combinations of diabetic drugs including dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled type type-2 diabetes.
In one trial, treatment with 5mg dapagliflozin and 5mg saxagliptin in addition to metformin demonstrated statistically-significant decreases in average blood glucose levels, and an increase in the number of patients achieving the recommended glucose levels treatment goal of less than 7%.
In the second trial, treatment with 10mg dapagliflozin and 5mg saxagliptin in addition to metformin extended release demonstrated statistically-significant decreases in glucose levels, and an increase in the number of patients achieving a blood glucose level of below 7%.
At 8:05am: [LON:AZN] AstraZeneca PLC share price was +35.5p at 5723.5p
Story provided by StockMarketWire.com
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