Sitagliptin/metformin explained

Type:combo
Component1:Sitagliptin
Class1:Dipeptidyl peptidase-4 inhibitor
Component2:Metformin
Class2:Biguanide
Tradename:Janumet, Januet, others
Dailymedid:Sitagliptin and metformin
Pregnancy Au:C
Routes Of Administration:By mouth
Atc Prefix:A10
Atc Suffix:BD07
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:[2]
Legal Uk:POM
Legal Uk Comment:[3]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Eu Comment:[4]
Legal Status:Rx-only
Kegg:D10261

Sitagliptin/metformin, sold under the brand name Janumet among others, is a fixed-dose combination anti-diabetic medication used to treat type 2 diabetes. It may be used in those whose blood sugar is not controlled with metformin and a sulfonylurea.[5] It is taken by mouth.[6]

Common side effects include diarrhea, headache, and upper respiratory tract infections. Serious side effects may include lactic acidosis, pancreatitis, low blood sugar, heart failure, joint pain, and allergic reactions. It has not been properly studied in women who are pregnant or breastfeeding.[7] It contains sitagliptin (a dipeptidyl peptidase-4 inhibitor) and metformin (a biguanide).

The combination was approved for medical use in the United States in 2007. In 2021, it was the 154th most commonly prescribed medication in the United States, with more than 3million prescriptions.[8] [9] It is available as a generic medication.[10] [11]

Medical uses

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.[12] [13]

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."[14]

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. The drugs are approved to improve blood sugar control in adults aged 18 and older with type 2 diabetes.[15]

Society and culture

Brand names

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.[16]

Notes and References

  1. Web site: Sitagliptin/metformin Sandoz XR (Sandoz Pty Ltd) . Therapeutic Goods Administration (TGA) . 2 June 2023 . 10 September 2023.
  2. Web site: Product monograph brand safety updates . Health Canada . February 2024 . 24 March 2024.
  3. Web site: Janumet 50 mg/1000 mg film-coated tablets - Summary of Product Characteristics (SmPC) . (emc) . 25 November 2020 . 5 December 2020 . 26 October 2020 . https://web.archive.org/web/20201026135010/https://www.medicines.org.uk/emc/product/564 . live .
  4. Web site: Efficib EPAR . European Medicines Agency . 16 July 2008 . 25 July 2024.
  5. Hayes J, Anderson R, Stephens JW . Sitagliptin/metformin fixed-dose combination in type 2 diabetes mellitus: an evidence-based review of its place in therapy . Drug Design, Development and Therapy . 10 . 2263–70 . 2016 . 27486305 . 4958358 . 10.2147/DDDT.S93076 . free .
  6. Book: British national formulary : BNF 76. 2018. Pharmaceutical Press. 9780857113382. 682. 76.
  7. Web site: Metformin / sitagliptin Use During Pregnancy . Drugs.com . 19 April 2019 . 19 April 2019 . https://web.archive.org/web/20190419032109/https://www.drugs.com/pregnancy/metformin-sitagliptin.html . live .
  8. Web site: The Top 300 of 2021 . ClinCalc . 14 January 2024 . 15 January 2024 . https://web.archive.org/web/20240115223848/https://clincalc.com/DrugStats/Top300Drugs.aspx . live .
  9. Web site: Metformin; Sitagliptin - Drug Usage Statistics . ClinCalc . 14 January 2024 .
  10. Web site: Sitagliptin / Metformin hydrochloride Accord EPAR . European Medicines Agency (EMA) . 17 May 2022 . 3 August 2022 . 3 August 2022 . https://web.archive.org/web/20220803220229/https://www.ema.europa.eu/en/medicines/human/EPAR/sitagliptin-metformin-hydrochloride-accord . live .
  11. Web site: Sitagliptin / Metformin hydrochloride Sun: Pending EC decision . European Medicines Agency (EMA) . 26 January 2023 . 28 January 2023 . 27 January 2023 . https://web.archive.org/web/20230127225414/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/sitagliptin-metformin-hydrochloride-sun . live .
  12. Web site: Janumet- sitagliptin and metformin hydrochloride tablet, film coated . DailyMed . 12 August 2019 . 5 December 2020 . 9 June 2021 . https://web.archive.org/web/20210609205430/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67 . live .
  13. Web site: Janumet XR- sitagliptin and metformin hydrochloride tablet, film coated, extended release . DailyMed . 5 December 2020 . 29 October 2020 . https://web.archive.org/web/20201029090737/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50 . live .
  14. Web site: Janumet EPAR . European Medicines Agency (EMA) . 5 December 2020 . 9 June 2021 . https://web.archive.org/web/20210609205518/https://www.ema.europa.eu/en/medicines/human/EPAR/janumet . live .
  15. Web site: New studies show diabetes drug not proven to improve blood sugar control in pediatric patients . U.S. Food and Drug Administration . 4 December 2020 . 5 December 2020 . 4 December 2020 . https://web.archive.org/web/20201204222229/https://www.fda.gov/drugs/drug-safety-and-availability/new-studies-show-diabetes-drug-not-proven-improve-blood-sugar-control-pediatric-patients . live .
  16. Web site: International brands for Sitagliptin/metformin . Drugs.com . 3 September 2018 . 23 August 2019 . https://web.archive.org/web/20190823111819/https://www.drugs.com/international/sitagliptin.html . live .

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