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

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2019-03, Vol.21 (3), p.715-719
• Main Authors: Bonadonna, Riccardo C., Yale, Jean‐François, Brulle‐Wohlhueter, Claire, Boëlle‐Le Corfec, Emmanuelle, Choudhary, Pratik, Bailey, Timothy S.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; basal insulin; Brief Report; Brief Reports; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - drug therapy; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Follow-Up Studies; Glucose; glycaemic control; Glycated Hemoglobin A - analysis; Glycated Hemoglobin A - drug effects; Glycated Hemoglobin A - metabolism; Hemoglobin; Humans; hypoglycaemia; Hypoglycemia; Hypoglycemia - blood; Hypoglycemia - chemically induced; Hypoglycemia - diagnosis; Insulin; Insulin Glargine - administration & dosage; Insulin Glargine - adverse effects; Intention to Treat Analysis; Male; Metformin - administration & dosage; Metformin - adverse effects; Middle Aged; Patients; type 2 diabetes; Young Adult
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.13578

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.