Hypoglycaemia as a function of HbA1c in type 2 diabetes: Insulin glargine 300 U/mL in a patient-level pooled analysis of EDITION 1, 2 and 3
Open accessAbstract
Basal insulin therapy often involves a compromise between achievement of glycaemic targets and avoidance of hypoglycaemia, dependent on how intensively insulin is titrated. In the Phase 3a EDITION 1, 2 and 3 studies, insulin glargine 300 U/mL (Gla-300) provided glycaemic control equivalent to that of insulin glargine 100 U/mL (Gla-100), with less hypoglycaemia in individuals with type 2 diabetes mellitus (T2DM). The current study evaluated the rates of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia over six months of treatment with Gla-300 or Gla-100 in the EDITION studies, as a function of HbA1c. Analysis was performed on patient-level data pooled from the three EDITION studies, and annualized hypoglycaemia rate as a function of HbA1c at Month 6 was fitted using a negative binomial regression model. Participants treated with Gla-300 experienced a consistently lower rate of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia as compared with those treated with Gla-100, regardless of HbA1c at Month 6. Results suggest that treatment with Gla-300 vs Gla-100 could allow individuals with T2DM to achieve equivalent glycaemic control with less hypoglycaemia.
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Metformin is widely used as a first-line treatment for type 2 diabetes mellitus owing to its excellent tolerability, safety profile, and lack of hypoglycemic effect.
“Isolated from French lilac in 1920s, metformin (dimethylbiguanide) has been widely used as a first-line treatment for type 2 diabetes mellitus (DM2), owing to its excellent tolerability, safety profile, and lack of hypoglycemic effect (3–6).”
From GDF-15 as a Weight Watcher for Diabetic and Non-Diabetic People Treated With Metformin (2020) · cites this paper as [6]
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Ouyang, J., Isnard, S., Lin, J., Fombuena, B., Peng, X., Chen, Y., & Routy, J.-P. (2020) · Frontiers in Endocrinology · doi:10.3389/fendo.2020.581839 · Cited by 39 · see citing works
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- Authors
- Bonadonna, R. C., Yale, J., Brulle‐Wohlhueter, C., Boëlle‐Le Corfec, E., Choudhary, P., & Bailey, T. S.
- Affiliations
- University of Parma (IT)
- McGill University (CA)
- Sanofi Paris France
- King's College London (GB)
- AMCR Institute (US)
- Corresponding author
- Bonadonna, Riccardo C.
- Venue
- Diabetes Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2018-12-09
- Volume
- 21
- Issue
- 3
- Pages
- 715-719
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- PMC
- PMC6587758
- OpenAlex
- W2899757702
- Cited by
- 7
- References
- 22
- Citations by year
- 2024: 1 · 2022: 1 · 2020: 2 · 2019: 1 · 2018: 1 · 2016: 1
- FWCI
- 0.80
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Obesity and Metabolism (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Research Portal (King's College London) (publishedVersion, other-oa)
- Funders
- Sanofi
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- hypoglycemia, insulin glargine 300 U/mL, insulin glargine 100 U/mL, type 2 diabetes, HbA1c, basal insulin therapy, glycemic control, severe hypoglycemia, insulin dose adjustment
- MeSH terms
- Insulin Glargine, Adolescent, Adult, Aged, Aged, 80 and over, Diabetes Mellitus, Type 2, Dose-Response Relationship, Drug, Drug Therapy, Combination, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Hypoglycemia, Male, Metformin, Middle Aged, Young Adult, Intention to Treat Analysis
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