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Diabetes Obes Metab. 2018 Feb;20(2):448-452. doi: 10.1111/dom.13071. Epub 2017 Sep 14.

Glycaemic control and hypoglycaemia in people with type 2 diabetes switching from twice-daily basal insulin to once-daily insulin glargine 300 U/mL or insulin glargine 100 U/mL (EDITION 1 and EDITION 2 subgroup analysis).

Author information

1
INSERM, UMRS 1138, Centre de Recherche des Cordeliers, Paris, France.
2
Département Hospitalo-Universitaire FIRE, Service de Diabétologie, Endocrinologie et Nutrition, UFR de Médecine, and Assistance Publique Hôpitaux de Paris, Hôpital Bichat, Université Paris Diderot, Sorbonne Paris Cité, Paris, France.
3
Department of Endocrinology and Diabetes, Royal Brisbane and Women's Hospital, Brisbane, Australia.
4
Department of Diabetes, Endocrinology and Clinical Pharmacology, Glasgow Royal Infirmary, Glasgow, UK.
5
Diabetes Reference Unit, Clinic University Hospital, Valencia, Spain.
6
Sanofi, Paris, France.
7
Diabetes and Endocrinology Center, Rockwood Clinic, Spokane, Washington.

Abstract

In this post hoc analysis we compared glycaemic control and hypoglycaemia between insulin glargine 300 U/mL (Gla-300) and glargine 100 U/mL (Gla-100) administered once daily in people with type 2 diabetes (T2DM) from the EDITION 1 (basal plus mealtime insulin) and EDITION 2 (basal insulin plus oral antihyperglycaemic drugs) trials who were previously receiving twice-daily insulin. At randomization, 16.9% and 20.0% of people in EDITION 1 and 2, respectively, were receiving twice-daily basal insulin. Glycated haemoglobin change from baseline to Month 6 was similar over 6 months with Gla-300 or Gla-100 (least squares mean difference -0.01%; 95% confidence interval [CI] -0.27 to 0.24] in EDITION 1 and 0.16%; 95% CI -0.25 to 0.57, in EDITION 2). Participants previously receiving twice-daily insulin in EDITION 1 had a lower risk of confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia with Gla-300 vs Gla-100 at night (00:00-05:59 hours), but not at any time (24 hours); in EDITION 2 the risk was reduced at night and any time (24 hours). In conclusion, Gla-300 provided similar glycaemic control with less hypoglycaemia compared with Gla-100 in people with T2DM switching from twice-daily to once-daily basal insulin.

KEYWORDS:

basal insulin; glycaemic control; hypoglycaemia; insulin analogues; phase III study; type 2 diabetes

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