One‐year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal‐time insulin: the EDITION 1 12‐month randomized trial, including 6‐month extension
Open accessAbstract
Aims: To evaluate the maintenance of efficacy and safety of insulin glargine 300 U/ml ( Gla‐300 ) versus glargine 100 U/ml ( Gla‐100 ) in people with type 2 diabetes mellitus ( T2DM ) using basal plus meal‐time insulin for 12 months in the EDITION 1 trial. Methods: EDITION 1 was a multicentre, randomized, open‐label, two‐arm, phase IIIa study. Participants completing the initial 6‐month treatment period continued to receive Gla‐300 or Gla‐100 , as previously randomized, once daily for a further 6‐month open‐label extension phase. Changes in glycated haemoglobin ( HbA1c ) and fasting plasma glucose concentrations, insulin dose, hypoglycaemic events and body weight were assessed. Results: Of 807 participants enrolled in the initial phase, 89% (359/404) assigned to Gla‐300 and 88% (355/403) assigned to Gla‐100 completed 12 months. Glycaemic control was sustained in both groups (mean HbA1c : Gla‐300 , 7.24%; Gla‐100 , 7.42%), with more sustained HbA1c reduction for Gla‐300 at 12 months: least squares mean difference Gla‐300 vs Gla‐100 : HbA1c −0.17 [95% confidence interval ( CI ) −0.30 to −0.05]%. The mean daily basal insulin dose at 12 months was 1.03 U/kg for Gla‐300 and 0.90 U/kg for Gla‐100 . Lower percentages of participants had ≥1 confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemic event with Gla‐300 than Gla‐100 at any time of day [24 h; 86 vs 92%; relative risk 0.94 (95% CI 0.89–0.99)] and during the night [54 vs 65%; relative risk 0.84 (95% CI 0.75–0.94)], while the annualized rates of such hypoglycaemic events were similar. No between‐treatment differences in adverse events were apparent. Conclusion: During 12 months of treatment of T2DM requiring basal and meal‐time insulin, glycaemic control was better sustained and fewer individuals reported hypoglycaemia with Gla‐300 than with Gla‐100 . The mean basal insulin dose was higher with Gla‐300 compared with Gla‐100 , but total numbers of hypoglycaemic events and overall tolerability did not differ between treatments.
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U-300 glargine has a longer duration of action than U-100 glargine but modestly lower efficacy per unit administered.
“U-300 glargine has a longer duration of action than U-100 glargine but modestly lower efficacy per unit administered (179-181).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [180]
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Research works printed but not linked: 12
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- Authors
- Riddle, M. C., Yki‐Järvinen, H., Bolli, G. B., Ziemen, M., Muehlen‐Bartmer, I., Cissokho, S., & Home, P. D.
- Affiliations
- Oregon Health & Science University (US)
- University of Helsinki (FI)
- University of Perugia (IT)
- Sanofi (Germany) (DE)
- Sanofi‐Aventis Deutschland GmbH Frankfurt am Main Germany
- Keyrus Biopharma Levallois‐Perret France
- Newcastle University (GB)
- Corresponding author
- Riddle, M. C.
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2015-05-11
- Volume
- 17
- Issue
- 9
- Pages
- 835-842
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- PMC
- PMC4676922
- OpenAlex
- W1544349623
- Cited by
- 110
- References
- 0
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 3 · 2023: 4 · 2022: 1 · 2021: 5 · 2020: 10 · 2019: 18 · 2018: 26 · 2017: 15 · 2016: 18 · 2015: 5
- FWCI
- 18.55
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Obesity and Metabolism (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Työväentutkimus Vuosikirja (submittedVersion)
- Newcastle University ePrints (Newcastle Univesity) (cc-by-nc-nd)
- Funders
- Sanofi
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- insulin glargine 300 U/mL, insulin glargine 100 U/mL, type 2 diabetes, glycemic control, HbA1c, hypoglycemia, basal insulin dose, long-acting insulin analogues, body weight, treatment efficacy and safety
- MeSH terms
- Insulin Glargine, Aged, Blood Glucose, Body Weight, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Drug Therapy, Combination, Fasting, Female, Glycated Hemoglobin, Humans, Hypoglycemia, Hypoglycemic Agents, Insulin, Male, Middle Aged, Time Factors, Treatment Outcome, Meals
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