The U.S. Food and Drug Administration has approved a combination drug to improve blood sugar control in people with Type 2 diabetes.
This combination of 10 or 25 mg of empagliflozin and 5 mg of linagliptin is called Glyxambi, and is intended for use in conjunction with diet and exercise. It is the first pill to combine a combination of a combination of a SGLT2 inhibitor and a DPP-4 inhibitor.
The FDA’s approval was based on a clinical trial in which 686 adults with adult onset diabetes, all of whom were also on high-dose metformin, were randomized and given either the combination drug or the individual components alone.
The trial found that Glyxambi reduced blood sugar levels better than either individual drug alone. In addition, a larger proportion of patients taking the combination drug (58 percent and 62 percent with 10 mg and 25 mg respectively) achieved a hemoglobin A1c level of below 7compared with those taking the individual drugs. An A1c level of below 7 is an important indicator of blood sugar control.
Glyxambi is not recommended in patients with diabetes Type 1 or for people with kidney problems or who are on dialysis. It also has not been studied in patients with a history of pancreatitis, and it is not known if the use of it would increase the risk of its development.
The new drug is manufactured by Eli Lilly and Boehringer Ingelheim.
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