FDA Approves New Combination Pill for Type 2 Diabetes

Xigduo XR for type 2 diabetes combines dapagliflozin and metformin

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new combination pill to treat type 2 diabetes.

The FDA approval is for Xigduo XR, which is manufactured by AstraZeneca. This two-in-one pill combines a newer AstraZeneca medication called dapagliflozin with metformin — the first-line treatment for type 2 diabetes.

Dapagliflozin is part of a class of medications known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. According to AstraZeneca, Xigduo XR is the first and only once-daily pill that combines an SGLT2 inhibitor and metformin to be approved in the US.

"The approval of once-daily Xigduo XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management," said Elisabeth Björk, head of Cardiovascular & Metabolism, Global Medicines Development, at AstraZeneca, in a press statement.

Type 2 diabetes is a condition in which the body becomes resistant to insulin. Insulin is a hormone that helps the body process and use blood sugar, or glucose. Insulin resistance causes blood sugar levels to rise. High blood sugar levels can lead to a variety of complications, such as heart disease, kidney damage and eye disease.

SGLT2 is a protein found mainly in the kidney. When blood is filtered through the kidneys, SGLT2 reabsorbs glucose back into the bloodstream. SGLT2 inhibitors like dapagliflozin reduce this reabsorption and allow excess glucose to leave the body through urine. Metformin is part of a class of medications that reduce the amount of glucose the liver produces.

Xigduo XR is meant to be used along with a healthy diet and regular exercise.

AstraZeneca warns that Xigduo XR is not recommended for people with type 1 diabetes or those with diabetic ketoacidosis — a serious complication of diabetes. The medication has a boxed warning — the FDA's strongest warning of possible side effects — for lactic acidosis. Lactic acidosis is a rare but serious complication that can happen because of a buildup of metformin.


Review Date: 
October 30, 2014
Last Updated:
November 3, 2014