Drugs / Insulin glargine U100
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Insulin glargine U100

also known as IGlar U100

Protein / enzyme biologic

Developed for
type 1 diabetes mellitus · diabetes mellitus · type 2 diabetes mellitus
Investigated by
Novo Nordisk A/S

Trials 1 · a red edge is where a trial was stopped

20192020202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT03766854 Dec 2018 → Dec 2019 type 1 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT03922750 Comparator May → Dec 2019 type 2 diabetes mellitus Novo Nordisk A/S Completed No outcome recorded
Phase 31 trial
Phase 3 NCT06767735 Comparator Feb 2025 → Aug 2026 overdue diabetes mellitus Gan & Lee Pharmaceuticals. Active not recruiting No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2024-01-08 Novo Nordisk A/S COMBINE 3 phase 3a trial successfully completed with once-weekly IcoSema demonstrating non-inferior reduction in HbA1c versus daily basal-bolus treatment (insulin glargine U100 and insulin aspart) in people with type 2 diabetes novonordisk.com
2022-06-03 Novo Nordisk A/S Novo Nordisk achieves primary objectives of ONWARDS 1 and 6 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin glargine U100 in ONWARDS 1 novonordisk.com
2016-11-29 Novo Nordisk A/S Novo Nordisk A/S: Tresiba® demonstrates a safe cardiovascular profile and reduces the risk of severe hypoglycaemia compared to insulin glargine U100 in the DEVOTE trial novonordisk.com
2016-02-23 Novo Nordisk A/S Tresiba® demonstrates significantly lower rate of hypoglycaemia than insulin glargine U100 in blinded phase 3b trial in people with type 1 diabetes novonordisk.com

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as Insulin glargine U100 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03922750
2

NCT03766854

NCT06767735

Known as IGlar U100 “once-daily insulin glargine 100 units/mL (IGlar U100)” PMID 33875485 Apr 2021
Modality Protein / enzyme biologic “once-daily insulin glargine 100 units/mL (IGlar U100)” PMID 33875485 Apr 2021
Route Subcutaneous “Participants will receive s.c. injections of insulin glargine once weekly for 2 weeks” NCT03766854