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Review
. 2018 Mar;20(3):541-548.
doi: 10.1111/dom.13105. Epub 2017 Oct 5.

Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL vs glargine 100 U/mL: 1-year patient-level meta-analysis of the EDITION clinical studies in people with type 2 diabetes

Robert Ritzel  1 , Ronan Roussel  2   3   4 , Andrea Giaccari  5 , Jiten Vora  6 , Claire Brulle-Wohlhueter  7 , Hannele Yki-Järvinen  8
Affiliations
Review

Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL vs glargine 100 U/mL: 1-year patient-level meta-analysis of the EDITION clinical studies in people with type 2 diabetes

Robert Ritzel et al. Diabetes Obes Metab. 2018 Mar.

Abstract

Aims: To investigate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) vs insulin glargine 100 U/mL (Gla-100) over 12 months in a patient-level meta-analysis, using data from the EDITION studies in people with type 2 diabetes (T2DM).

Methods: EDITION 1, 2 and 3 were multicentre, randomized, open-label, 2-arm, parallel-group, treat-to-target phase IIIa studies. Similar study designs and endpoints enabled a meta-analysis to be conducted.

Results: Reductions in glycated haemoglobin (HbA1c) were better sustained over 12 months with Gla-300 than with Gla-100 (least squares [LS] mean difference in change from baseline: -0.10 % [95% confidence interval {CI} -0.18 to -0.02] or -1.09 mmol/mol [95% CI -2.01 to -0.20]; P = .0174). Risk of confirmed (≤3.9 mmol/L) or severe hypoglycaemia was 15% lower with Gla-300 vs Gla-100 at night (relative risk 0.85 [95% CI 0.77-0.92]) and 6% lower at any time of day (relative risk 0.94 [95% CI 0.90-0.98]). Rates of hypoglycaemia were 18% lower with Gla-300 vs Gla-100 at night (rate ratio 0.82 [95% CI 0.67-0.99]), but comparable at any time of day. HbA1c <7.0 % without nocturnal hypoglycaemia was achieved by 24% more participants with Gla-300 than with Gla-100 (relative risk 1.24 [95% CI 1.03-1.50]). Severe hypoglycaemia was rare; in both treatment groups the incidence of events at any time of day was ≤3.6%, while rates were ≤0.08 events per participant-year.

Conclusions: In a broad population of people with T2DM over 12 months, use of Gla-300 provided more sustained glycaemic control and significantly lower hypoglycaemia risk at night and at any time of day compared with Gla-100.

Keywords: glycaemic control; hypoglycaemia; insulin analogues; meta-analysis; phase III study; type 2 diabetes.

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Conflict of interest statement

R. Ritzel has served as a consultant for AstraZeneca, Merck (MSD), Novo Nordisk, Servier and Sanofi and on the speakers bureau for AstraZeneca, Bristol‐Myers Squibb, Eli Lilly, Merck (MSD), Novartis, Novo Nordisk and Sanofi. R. Roussel has served on advisory panels for AstraZeneca, Eli Lilly and Physiogenex, as a board member for Janssen, Merck (MSD), Novo Nordisk, Sanofi, and as a consultant for Eli Lilly, and has received research support from Amgen and Sanofi. A. G. has served as a consultant for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Sanofi and Takeda, has received research support from AstraZeneca and Merck (MSD), and has served on the speakers bureau for AstraZeneca. J. V. has received research support and served on the advisory panel and speakers bureau for Abbott, AstraZeneca, Boehringer Ingelheim, Bristol‐Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck (MSD), Novartis, Novo Nordisk, Roche, Sanofi and Takeda. C. B.‐W. is an employee of Sanofi. H. Y.‐J. has served on the advisory panel for Eli Lilly, Merck (MSD) and Sanofi, and as a consultant for Eli Lilly and Sanofi.

Figures

Figure 1
Figure 1
HbA1c (mean ± s.e.) over the 12‐month treatment period (mITT population). LS mean difference analysed using a mixed model for repeated measures. BL, baseline; M, month; W, week
Figure 2
Figure 2
Percentage of participants with ≥1 hypoglycaemic event and annualized event rate (events per participant‐year) over the 12‐month treatment period (safety population). RR, relative risk for percentage of participants with ≥1 event, rate ratio for annualized event rates
Figure 3
Figure 3
Confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia by time of day over the 12‐month treatment period. A, Percentage of participants with ≥1 event and B, annualized event rates (events per participant‐year; safety population)
Figure 4
Figure 4
Percentage of participants achieving HbA1c targets (HbA1c <7.0 % or <7.5 % or HbA1c reduction ≥0.5 %) at month 12 without confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia over 12 months of treatment (mITT population). RR, relative risk
Figure 5
Figure 5
A, Mean (± s.e.) daily basal insulin dose over 12 months of treatment (mITT population) and B, mean (± s.e.) change in body weight from baseline to month 12 (safety population). BL, baseline; M, month; W, week
See this image and copyright information in PMC

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