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Basal insulin peglispro versus insulin glargine in insulin-naive type 2 diabetes: IMAGINE 2 randomized trial.


ABSTRACT: AIMS:To compare, in a double-blind, randomized, multi-national study, 52- or 78-week treatment with basal insulin peglispro or insulin glargine, added to pre-study oral antihyperglycaemic medications, in insulin-naïve adults with type 2 diabetes. MATERIAL AND METHODS:The primary outcome was non-inferiority of peglispro to glargine with regard to glycated haemoglobin (HbA1c) reduction (margin?=?0.4%). Six gated secondary objectives with statistical multiplicity adjustments focused on other measures of glycaemic control and safety. Liver fat content was measured using MRI, in a subset of patients. RESULTS:Peglispro was non-inferior to glargine in HbA1c reduction [least-squares (LS) mean difference: -0.29%, 95% confidence interval (CI) -0.40, -0.19], and had a lower nocturnal hypoglycaemia rate [relative rate 0.74 (95% CI 0.60, 0.91); p?=?.005), more patients achieving HbA1c <7.0% without nocturnal hypoglycaemia [odds ratio (OR) 2.15 (95% CI 1.60, 2.89); p?

SUBMITTER: Davies MJ 

PROVIDER: S-EPMC5096014 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Basal insulin peglispro versus insulin glargine in insulin-naïve type 2 diabetes: IMAGINE 2 randomized trial.

Davies M J MJ   Russell-Jones D D   Selam J-L JL   Bailey T S TS   Kerényi Z Z   Luo J J   Bue-Valleskey J J   Iványi T T   Hartman M L ML   Jacobson J G JG   Jacober S J SJ  

Diabetes, obesity & metabolism 20160812 11


<h4>Aims</h4>To compare, in a double-blind, randomized, multi-national study, 52- or 78-week treatment with basal insulin peglispro or insulin glargine, added to pre-study oral antihyperglycaemic medications, in insulin-naïve adults with type 2 diabetes.<h4>Material and methods</h4>The primary outcome was non-inferiority of peglispro to glargine with regard to glycated haemoglobin (HbA1c) reduction (margin = 0.4%). Six gated secondary objectives with statistical multiplicity adjustments focused  ...[more]

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