Sitagliptin/metformin
Combination of
SitagliptinDipeptidyl peptidase-4 inhibitor
MetforminBiguanide
Clinical data
Trade namesJanumet, Januet, others
AHFS/Drugs.comProfessional 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]

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.[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]

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.[15]

References

  1. ^ a b "Metformin / sitagliptin Use During Pregnancy". Drugs.com. Archived from the original on 19 April 2019. Retrieved 19 April 2019.
  2. ^ "Sitagliptin/metformin Sandoz XR (Sandoz Pty Ltd)". Therapeutic Goods Administration (TGA). 2 June 2023. Retrieved 10 September 2023.
  3. ^ "Product monograph brand safety updates". Health Canada. February 2024. Retrieved 24 March 2024.
  4. ^ "Janumet 50 mg/1000 mg film-coated tablets - Summary of Product Characteristics (SmPC)". (emc). 25 November 2020. Archived from the original on 26 October 2020. Retrieved 5 December 2020.
  5. ^ a b c d e f "Janumet- sitagliptin and metformin hydrochloride tablet, film coated". DailyMed. 12 August 2019. Archived from the original on 9 June 2021. Retrieved 5 December 2020.
  6. ^ a b "Janumet XR- sitagliptin and metformin hydrochloride tablet, film coated, extended release". DailyMed. Archived from the original on 29 October 2020. Retrieved 5 December 2020.
  7. ^ a b "Janumet EPAR". European Medicines Agency (EMA). Archived from the original on 9 June 2021. Retrieved 5 December 2020.
  8. ^ a b c British national formulary : BNF 76 (76 ed.). Pharmaceutical Press. 2018. p. 682. ISBN 9780857113382.
  9. ^ Hayes J, Anderson R, Stephens JW (2016). "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. doi:10.2147/DDDT.S93076. PMC 4958358. PMID 27486305.
  10. ^ "The Top 300 of 2021". ClinCalc. Archived from the original on 15 January 2024. Retrieved 14 January 2024.
  11. ^ "Metformin; Sitagliptin - Drug Usage Statistics". ClinCalc. Retrieved 14 January 2024.
  12. ^ "Sitagliptin / Metformin hydrochloride Accord EPAR". European Medicines Agency (EMA). 17 May 2022. Archived from the original on 3 August 2022. Retrieved 3 August 2022.
  13. ^ "Sitagliptin / Metformin hydrochloride Sun: Pending EC decision". European Medicines Agency (EMA). 26 January 2023. Archived from the original on 27 January 2023. Retrieved 28 January 2023.
  14. ^ a b "New studies show diabetes drug not proven to improve blood sugar control in pediatric patients". U.S. Food and Drug Administration. 4 December 2020. Archived from the original on 4 December 2020. Retrieved 5 December 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  15. ^ "International brands for Sitagliptin/metformin". Drugs.com. Archived from the original on 23 August 2019. Retrieved 3 September 2018.


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