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Rissanen, A.; Howard, C. P.; Botha, J.; Thuren, T.
Diabetes, obesity & metabolism, December 2012, Volume: 14, Issue: 12Journal Article
Aims Evaluate anti‐interleukin‐1β (IL‐1β) antibody, canakinumab, in patients with type 2 diabetes and impaired glucose tolerance (IGT) in whom hyperglycaemia may trigger IL‐1β‐associated inflammation leading to suppressed insulin secretion and β‐cell dysfunction. Methods This 4‐week, parallel‐group study randomized 190 patients with type 2 diabetes 2 : 1, canakinumab versus placebo, into the following treatment arms: metformin monotherapy, metformin + sulfonylurea, metformin + sulfonylurea + thiazolidinedione or insulin ± metformin. IGT population (n = 54) was randomized 1 : 1, canakinumab versus placebo. Primary efficacy assessment was change from baseline in insulin secretion rate (ISR) relative to glucose 0–2 h. Results Mean changes from baseline to week 4 in ISR relative to glucose at 0–2 h or other time points were not statistically significant for canakinumab versus placebo across groups. ISR (relative to glucose) at 0–0.5 h (first‐phase insulin secretion) numerically favoured canakinumab versus placebo in insulin‐treated patients {difference in mean change from baseline point estimate (PE) 3.81 pmol/min/m2/mmol/l; p = 0.0525} and in the IGT group (PE 3.92 pmol/min/m2/mmol/l; p = 0.1729). Mean change from baseline in fasting plasma glucose favoured canakinumab in the type 2 diabetes/metformin group and the IGT group; however, differences were not statistically significant. Mean change from baseline in peak insulin level and insulin AUC 0–4 h were statistically significantly higher in the canakinumab group in IGT patients. Canakinumab was well tolerated and consistent with known safety experience. Conclusions The trend towards improving ISR relative to glucose 0–0.5 h in patients treated with insulin supports the hypothesis that insulin secretion can be improved by blocking IL‐1β.
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