Combination Drug for Adults with T2D is Granted FDA Approval

Article

Dapagliflozin is a selective sodium‑glucose cotransporter-2 (SGLT-2) inhibitor that is combined with a dipeptidyl peptidase‑4 (DPP‑4) inhibitor, saxagliptin; and metformin hydrochloride extended release.

Officials with the FDA have approved AstraZeneca’s dapagliflozin, saxagliptin and metformin hydrochloride (Qternmet XR) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D), according to the company.

The combination drug is a once-daily, oral medicine. Dapagliflozin is a selective sodium‑glucose cotransporter-2 (SGLT-2) inhibitor that is combined with a dipeptidyl peptidase‑4 (DPP‑4) inhibitor, saxagliptin; and metformin hydrochloride extended release.

The approval is based on 2 Phase III trials that evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2D, said AstraZeneca officials, in a press release.

In the first trial, treatment with 5mg dapagliflozin/5mg saxagliptin in addition to metformin demonstrated statistically-significant decreases in HbA1c (average blood glucose levels), and an increase in the number of patients achieving the recommended HbA1c treatment goal of <7%.

In the second trial, treatment with 10mg dapagliflozin/5mg saxagliptin in addition to metformin extended release demonstrated statistically-significant decreases in HbA1c, and an increase in the number of patients achieving an HbA1c <7%.

The safety results of the individual medicines in these trials were consistent with their known profile.

Reference

Qternmet XR approved in the US for the treatment of type-2 diabetes [news release]. Cambridge, United Kingdom; May 3, 2019: AstraZeneca. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/qternmet-xr-approved-in-the-us-for-the-treatment-of-type-2-diabetes-03052019.html. Accessed May 6, 2019.

Related Videos
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
Image credit: Andrea Izzotti
Inflation Reduction Act is shown using the text and the US flag - Image credit: Andrii | stock.adobe.com
Pharmacy Interior | Image Credit: Tyler Olson - stock.adobe.com
Patient with diabetes testing blood sugar levels
Male pharmacist selling medications at drugstore to a senior woman customer | Image Credit: Zamrznuti tonovi - stock.adobe.com
Pharmacist assists senior woman in buying medicine in pharmacy - Image credit: Drazen | stock.adobe.com
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store - Image credit: C Daniels/peopleimages.com | stock.adobe.com
Image credit: fidaolga - stock.adobe.com
© 2023 MJH Life Sciences

All rights reserved.