Combination of | |
---|---|
Sitagliptin | Dipeptidyl peptidase-4 inhibitor |
Metformin | Biguanide |
Clinical data | |
Trade names | Janumet, Januet, others |
AHFS/ Drugs.com | Professional Drug Facts |
License data | |
Pregnancy category |
|
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
KEGG |
Sitagliptin/metformin, sold under the brand name Janumet among others, is a fixed-dose combination anti-diabetic medication used to treat type 2 diabetes. [8] It may be used in those whose blood sugar is not controlled with metformin and a sulfonylurea. [8] [9] It is taken by mouth. [8]
Common side effects include diarrhea, headache, and upper respiratory tract infections. [5] Serious side effects may include lactic acidosis, pancreatitis, low blood sugar, heart failure, joint pain, and allergic reactions. [5] It has not been properly studied in women who are pregnant or breastfeeding. [1] It contains sitagliptin (a dipeptidyl peptidase-4 inhibitor) and metformin (a biguanide). [5]
The combination was approved for medical use in the United States in 2007. [5] In 2021, it was the 154th most commonly prescribed medication in the United States, with more than 3 million prescriptions. [10] [11] It is available as a generic medication. [12] [13]
In the United States, sitagliptin/metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. [5] [6]
In the European Union, sitagliptin/metformin is indicated as an adjunct to diet and exercise to improve glycemic control in people with type 2 diabetes; in combination with a sulfonylurea as an adjunct to diet and exercise "in people inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea; as triple combination therapy with a peroxisome proliferator-activated receptor (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in people inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist; and as add-on to insulin as an adjunct to diet and exercise to improve glycemic control in people when stable dosage of insulin and metformin alone do not provide adequate glycemic control." [7]
In December 2020, the U.S. Food and Drug Administration (FDA) approved labeling changes stating that Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride), and Janumet XR (sitagliptin and metformin hydrochloride extended-release) are not proven to improve glycemic (blood sugar) control in children aged 10 to 17 with type 2 diabetes. [14] The drugs are approved to improve blood sugar control in adults aged 18 and older with type 2 diabetes. [14]
As of 2018, the combination is marketed under several brand names, including Efficib, Janmet, Januet, Janumet, Jznumet, Ristaben Met, Ristfor, Siglimet, Sitamet, Sitar-M, Sliptin-M, Treviamet, Velmetia, Istamet, Emsita, Sitaglyn, Sitazit-M and Zaxoran. [15]