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, Ronan Roussel, Andrea Giaccari, Jiten Vora, Claire Brulle-Wohlhueter, Hannele Yki-Järvinen

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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.

Original languageEnglish
Pages (from-to)541-548
Number of pages8
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number3
DOIs
Publication statusPublished - Mar 1 2018

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Hypoglycemia
Type 2 Diabetes Mellitus
Meta-Analysis
Confidence Intervals
Clinical Studies
Insulin Glargine
Glycosylated Hemoglobin A
Least-Squares Analysis
Safety

Keywords

  • glycaemic control
  • hypoglycaemia
  • insulin analogues
  • meta-analysis
  • phase III study
  • type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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. / Ritzel, Robert; Roussel, Ronan; Giaccari, Andrea; Vora, Jiten; Brulle-Wohlhueter, Claire; Yki-Järvinen, Hannele.

In: Diabetes, Obesity and Metabolism, Vol. 20, No. 3, 01.03.2018, p. 541-548.

Research output: Contribution to journalArticle

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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.",
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T1 - Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL vs glargine 100 U/mL

T2 - 1-year patient-level meta-analysis of the EDITION clinical studies in people with type 2 diabetes

AU - Ritzel, Robert

AU - Roussel, Ronan

AU - Giaccari, Andrea

AU - Vora, Jiten

AU - Brulle-Wohlhueter, Claire

AU - Yki-Järvinen, Hannele

PY - 2018/3/1

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N2 - 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.

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KW - hypoglycaemia

KW - insulin analogues

KW - meta-analysis

KW - phase III study

KW - type 2 diabetes

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