Commentary by: J. Michael Gonzalez-Campoy, MD, PhD, FACE
Glyxambi (empagliflozin/linagliptin) is now approved in addition to a healthy meal plan and physical activity, for the treatment of type 2 diabetes. Glyxambi, from Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, is the first ever combination treatment containing the diabetes medications empagliflozin and linagliptin in a once daily pill.
Empagliflozin and linagliptin are from two different classes of medication, lowering blood sugar levels in different ways. Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor that blocks sugar (or glucose) from being reabsorbed in the kidneys. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases hormones that cause the pancreas to produce more insulin and stimulate the liver to produce less glucose.
"Treating diabetes is like playing tug of war," said J. Michael Gonzalez-Campoy, MD, PhD, FACE, Medical Director and Chief Executive Officer of the Minnesota Center for Obesity, Metabolism and Endocrinology in Eagan, Minnesota. "This medication puts TWO sets of hands on the tug of war rope, bringing glucoses closer to treatment goal," Dr. Gonzalez-Campoy said.
Glyxambi is available in two doses: 10 mg or 25 mg of empagliflozin plus 5 mg of linagliptin.
Approval by the U.S. Food and Drug Administration was based on a study showing that both doses of Glyxambi (given along with metformin) were safe and more effective at lowering blood sugar levels than empagliflozin or linagliptin alone. A greater percentage of people taking Glyxambi (58%-62%) were able to achieve a hemoglobin A1c level of <7% (a goal recommended for most people by the American Diabetes Association) than people taking empagliflozin or linagliptin alone (28%-36%).
Glyxambi also led to more weight loss than treatment with linagliptin alone.
"Using medications that have a weight advantage, such as Glyxambi, is recommended over the use of medications associated with weight gain and hypoglycemia risk, such as sulfonylureas and insulin," Dr. Gonzalez-Campoy said.
The most common side effects of Glyxambi were urinary tract infections, stuffy or runny nose and sore throat, and upper respiratory tract infections.
Glyxambi should not be taken by patients with severe kidney impairment or who are on dialysis; a history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity; or history of serious hypersensitivity reaction to empagliflozin.
Postmarketing reports of acute pancreatitis, including fatal pancreatitis, have occurred in patients taking linagliptin. Treatment should be discontinued in patients who develop pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of this disorder while using the Glyxambi because the combination treatment has not been studied in patients with a history of pancreatitis.
DeFronzo RA, Lewin A, Patel S, et al. Combination of Empagliflozin and Linagliptin as Second-Line Therapy in Subjects With Type 2 Diabetes Inadequately Controlled on Metformin. Diabetes Care. 2015 Jan 12. pii: dc142364. [Epub ahead of print]
Eli Lilly and Company. U.S. FDA Approves First-In-Class Glyxambi (Empagliflozin/Linagliptin) Tablets For Adults With Type 2 Diabetes. February 2, 2015. http://lilly.mediaroom.com/index.php?s=9042&item=137386. Accessed February 11, 2015.