Modulation of insulin dose titration by a hypoglycaemia sensitive algorithm:
Accepted Article
insulin glargine vs. NPH insulin in insulin-naïve people with type 2 diabetes
P. D. Home1, G.B. Bolli2, C. Mathieu3, C. Deerochanawong4, W. Landgraf5, C. Candelas6, V. Pilorget6, M.-P. Dain6 & M.C. Riddle7
1
Institute for Cellular Medicine - Diabetes, Newcastle University, Newcastle upon Tyne, United
Kingdom; 2Department of Medicine, University of Perugia, Perugia, Italy; 3Department of
Endocrinology, University Hospital Gasthuisberg, Leuven, Belgium; 4Rajavithi Hospital, College of Medicine, Rangsit University, Ministry of Public Health, Bangkok, 10400, Thailand; 5Sanofi, Frankfurt, Germany; 6Sanofi, Paris, France; 7Oregon Health & Science University, Portland, OR,
USA Correspondence to: Professor Philip Home, Institute for Cellular Medicine – Diabetes, Newcastle University, The Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.
[email protected] Keywords: hypoglycaemia-sensitive algorithm; insulin glargine; NPH insulin
This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1111/dom.12326
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Abstract Aims: Insulin glargine causes less nocturnal hypoglycaemia than human NPH insulin in treat-totarget studies in insulin-naïve people with type 2 diabetes. The present study examined whether this clinical benefit can lead to superior control of HbA1c with glargine, using a protocol
Accepted Article
designed to limit nocturnal hypoglycaemia. Methods: LANCELOT was a 36-week, randomized, open-label, parallel-arm study conducted in Europe, Asia, Middle East and South America. Participants were randomized (1:1) to begin glargine or NPH, on background of metformin with glimepiride. Weekly insulin titration aimed to achieve median pre-breakfast and nocturnal plasma glucose ≤5.5 mmol/l while limiting values
≤4.4 mmol/l. Results: The efficacy population (n=701) had mean age 57 years, BMI 29.8 kg/m2, duration of diabetes 9.2 years, HbA1c 66 mmol/mol (8.2%). At treatment end, HbA1c values and the proportion of people with HbA1c