Drugs / glargine insulin

Trials 6

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07588906 Feb → Jul 2024 — Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT00640991 Apr 2008 → Jun 2010 hyperglycemia, myocardial infarction Population Health Research Institute Completed No outcome recorded
Phase 3 NCT00222521 Apr 2003 → Aug 2005 cystic fibrosis-related diabetes University of Minnesota Completed No outcome recorded
Phase 42 trials
Phase 4 NCT02451917 Dec 2013 → Aug 2016 chronic kidney disease, type 2 diabetes mellitus University of Sao Paulo General Hospital Completed Mixed
Phase 4 NCT00340613 Jun 2006 → Jun 2007 type 1 diabetes mellitus Baylor College of Medicine Completed No outcome recorded
Phase not applicable1 trial
— NCT01045954 Jan → Aug 2010 type 1 diabetes mellitus Diabetes Care Center Unknown No outcome recorded
Comparator or background therapy6 trials
Phase 3 NCT01792830 Comparator Oct 2012 → Feb 2014 glucose metabolism disease Emory University Completed No outcome recorded
Phase 4 NCT02216799 Comparator Mar 2013 → Aug 2015 — King Faisal Specialist Hospital & Research Center Completed No outcome recorded
Phase 4 NCT01203774 Comparator Sep 2010 → Aug 2013 diabetes mellitus University of Colorado, Denver Completed No outcome recorded
Phase 4 NCT01211730 Comparator Apr 2009 → Dec 2015 hyperglycemia Northwestern University Completed No outcome recorded
Phase 4 NCT00353834 Comparator Aug 2006 → Sep 2010 type 2 diabetes mellitus Joslin Diabetes Center Completed No outcome recorded

Press releases naming this drug 7 releases

DateIssuerRelease
2026-06-05 Gan and Lee Pharmaceuticals, USA Gan & Lee’s Once-Weekly Basal insulin GZR4 Injection Met the Primary Endpoint in the Pivotal Phase 3 SUPER-3 Trial and Demonstrated Superior HbA1c Reduction Versus Insulin Glargine U100 ganlee.com ↗
2024-08-22 Gan and Lee Pharmaceuticals, USA Gan & Lee’s Insulin Glargine U300 Clinical Research Findings Published in Frontiers in Endocrinology ganlee.com ↗
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 ↗
2023-08-21 Gan and Lee Pharmaceuticals, USA The Scientific Evaluation from EMA on Marketing Authorisation Application of Gan & Lee Insulin Glargine biosimilar starts upon the Positive Validation Letter ganlee.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 6 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Glargine insulin “glargine insulin” NCT01211730 ↗
11

NCT01792830 ↗

NCT07588906 ↗

NCT02216799 ↗

NCT00609986 ↗

NCT00353834 ↗

NCT00222521 ↗

NCT01045954 ↗

NCT00640991 ↗

NCT00340613 ↗

NCT01203774 ↗

Show 1 more source

Known as glargine U100 “The purpose of this study was to compare the glycemic response to treatment with glargine U100 or neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes...” PMID 31383366 ↗ Aug 2019
Known as insulin glargine “Treatment with insulin glargine reduced the incidence of confirmed hypoglycaemia and confirmed nocturnal hypoglycaemia.” PMID 33166419 ↗ Nov 2020
Known as LANTUS (insulin glargine [rDNA origin] injection “LANTUS (insulin glargine [rDNA origin] injection” NCT02216799 ↗
Modality Protein / enzyme biologic “Glargine is a recombinant human insulin analog” NCT01792830 ↗
Route Subcutaneous “The NPH or glargine and aspartame insulin will be given subcutaneously using a small-short needle to administer the insulin.” NCT00609986 ↗