Drugs / Insulin glargine U100
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03766854 | Dec 2018 → Dec 2019 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT03922750 Comparator | May → Dec 2019 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Mixed |
| Phase 3 | NCT06767735 Comparator | Feb 2025 → Aug 2026 overdue | diabetes mellitus | Gan & Lee Pharmaceuticals. | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-03-30 | Gan and Lee Pharmaceuticals, USA | Results Gan & Lee Pharmaceuticals’ Once-Weekly Basal Insulin GZR4 Injection Meets Primary Endpoints in Two Pivotal Phase 3 Clinical Trials: SUPER-1 and SUPER-2 ganlee.com ↗
After 26 weeks of treatment, once-weekly GZR4 demonstrated statistically significant superior efficacy in reducing glycated hemoglobin A1c (HbA1c) * compared with once-daily insulin glargine U100 (Lantus ® ) and once-daily insulin degludec (Tresiba ® ). |
| 2024-01-08 | Novo Nordisk A/S | Results 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 ↗
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart. |
| 2022-10-03 | Novo Nordisk A/S | Results Once-weekly insulin icodec demonstrates superior reduction in HbA1c in combination with a dosing guide app versus once-daily basal insulin in people with type 2 diabetes in ONWARDS 5 phase 3a trial novonordisk.com ↗
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared with once-daily basal insulin analogues. |
| 2022-07-29 | Novo Nordisk A/S | Results Novo Nordisk achieves primary objectives of ONWARDS 3 and 4 trials with once-weekly insulin icodec demonstrating superior reduction in HbA1c vs insulin degludec in ONWARDS 3 novonordisk.com ↗
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin icodec compared with insulin glargine. |
| 2022-06-03 | Novo Nordisk A/S | Results 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 ↗
From an overall baseline HbA1c of 8.5% once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of -1.55% compared to -1.35% for insulin glargine (estimated treatment difference: -0.19%). |
| 2017-05-27 | Novo Nordisk A/S | Results Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba® label novonordisk.com ↗
In the DEVOTE trial, the primary endpoint was achieved by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba® compared to insulin glargine U100. |
| 2016-11-29 | Novo Nordisk A/S | Results 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 ↗
The trial achieved its primary endpoint by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba® compared to insulin glargine U100. |
| 2016-11-10 | Novo Nordisk A/S | Results Novo Nordisk submits application in the EU for including data from the two SWITCH trials in Tresiba® label novonordisk.com ↗
During the study's maintenance period, people treated with Tresiba® on average had 11% fewer episodes of overall symptomatic blood glucose confirmed hypoglycaemia, 36% fewer episodes of nocturnal blood glucose confirmed symptomatic hypoglycaemia and 35% fewer episodes of severe hypoglycaemia. |
| 2016-02-23 | Novo Nordisk A/S | Results Tresiba® demonstrates significantly lower rate of hypoglycaemia than insulin glargine U100 in blinded phase 3b trial in people with type 1 diabetes novonordisk.com ↗
The observed rate was 2,201 events per 100 patient years exposed to Tresiba® and 2,463 events per 100 patient years exposed to insulin glargine during the maintenance period, corresponding to a statistically significant reduction of 11%. |
All press releases naming this drug 9 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Insulin glargine U100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03922750 ↗ |
| 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 ↗ |