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FDA Approves Qternmet XR for Type 2 Diabetes

In May 2019, the United States FDA (Food and Drug Administration) approved Qternmet XR for adults with type 2 diabetes. Qternmet XR extended-release tablets are a combination of dapagliflozin, saxagliptin, and metformin hydrochloride. Qternmet XR is used to help improve blood sugar control and is indicated for use in adults with type 2 diabetes, in addition to diet and exercise. Qternmet XR is manufactured by AstraZeneca.

How does Qternment XR work?

The different medications in Qternmet XR work in various ways to help improve glycemic control. Dapagliflozin is a SGLT-2 (sodium-glucose cotransporter-2) inhibitor, which can help the kidneys get rid of more glucose in the urine, as well as prevent the kidneys from reabsorbing glucose back into the body. Saxagliptin is a DPP-4 (dipeptidyl peptidase-4) inhibitor which acts to increase the amount of insulin produced by the body. Metformin helps make cells more sensitive to insulin, as well as decreases the amount of glucose made by the liver. All three medications work together to improve blood sugar control.

Is Qternmet XR safe and effective?

The safety and efficacy of Qternmet XR were determined based on the results of two Phase III clinical trials. Both trials investigated treatment with saxagliptin and dapagliflozin in addition to metformin over the course of 24 weeks. These studies looked specifically at adults with inadequately-controlled type 2 diabetes.

One trial investigated the use of 10mg dapagliflozin and 5 mg saxagliptin (alongside extended release metformin) and found that those taking the new treatment regimen had a statistically significant decrease in average blood glucose levels (as measured by HbA1c level). The second study researched the use of 5mg dapagliflozin and 5 mg saxagliptin (alongside metformin) and also found that those taking the new regimen had statistically significant decreases in their HbA1c levels. Both studies had an increase in the number of participants achieving an HbA1c <7%, and found that the safety of the individual medications involved in the combination treatment was consistent with each drug on its own.1

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  1. Qternmet XR Approved in the US for the Treatment of Type-2 Diabetes. AstraZeneca. Published May 3, 2019. Accessed May 6, 2019.