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Diabetes Obes Metab. 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.

Author information

1
Division of Endocrinology and Diabetes, Klinikum Schwabing and Klinikum Bogenhausen, Städtisches Klinikum München GmbH, Munich, Germany.
2
INSERM, U-1138, Centre de Recherche des Cordeliers, Paris, France.
3
UFR de Médecine, Université Paris Diderot, Sorbonne Paris Cité, Paris, France.
4
Départment de Diabétologie, Endocrinologie et Nutrition, Assistance Publique Hôpitaux de Paris, Hôpital Bichat, DHU FIRE, Paris, France.
5
Center for Endocrine and Metabolic Diseases, Fondazione Policlinico Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
6
Department of Endocrinology, Royal Liverpool University Hospital, Liverpool, UK.
7
Diabetes Division, Sanofi, Paris, France.
8
Department of Medicine, University of Helsinki, Helsinki, Finland.

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

PMID:
28862801
PMCID:
PMC5836995
DOI:
10.1111/dom.13105
[Indexed for MEDLINE]
Free PMC Article

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