Last reviewed · How we verify
NCT02855684: EDITION AP
Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy
Phase 3 trial testing Insulin glargine (U300) in Type 2 Diabetes Mellitus in 604 participants. Completed in 6 August 2018.
6 August 2018
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 604 |
| Start date | 24 August 2016 |
| Primary completion | 6 August 2018 |
| Estimated completion | 6 August 2018 |
| Sites | 54 locations across China, Taiwan, South Korea |
Drugs / interventions tested
- Insulin glargine (U300) — full drug profile →
- Insulin glargine (INSULIN GLARGINE) — full drug profile →
- Non-insulin antihyperglycemic drugs — full drug profile →
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Sanofi — full company profile →
Who can join
18 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objective: To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes mellitus. Secondary Objectives: * To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia. * To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia). * To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia). * To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative). * To assess the safety and tolerability of insulin glargine (U300). * To assess the development of anti-insulin glargine antibodies (AIA).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy and safety of insulin glargine 300 U/mL versus insulin glargine 100 U/mL in Asia Pacific insulin-naïve people with type 2 diabetes: The EDITION AP randomized controlled trial.
Ji L, Kang ES, Dong X, Li L, et al · · 2020 · cited 23× · PMID 31797549 · DOI 10.1111/dom.13936 -
56<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
· 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5
Verify or expand the search:
- PubMed search for NCT02855684
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Insulin glargine (U300)
Trials testing the same drug.
- NCT04980027 — Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabe · Phase 4 · completed
- NCT03703869 — Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® Aft · completed
Other recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
- NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
- NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
- NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
- NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
- NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting
Other Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02855684 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 25 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02855684.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing