Basal insulin peglispro versus insulin glargine in insulin-naïve 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 < .001], greater HbA1c reduction (p < .001), and more patients achieving HbA1c<7.0% [OR 1.97 (95% CI 1.57, 2.47); p < .001]. Total hypoglycaemia rate and fasting serum glucose did not achieve statistical superiority. At 52 weeks, peglispro-treated patients had higher triglyceride (1.9 vs 1.7 mmol/L). alanine transaminase (34 vs 27 IU/L), and aspartate transaminase levels (27 vs 24 IU/L). LS mean liver fat content was unchanged with peglispro at 52 weeks but decreased 3.1% with glargine [difference: 2.6% (0.9, 4.2); p = .002]. More peglispro-treated patients experienced adverse injection site reactions (3.5% vs 0.6%, p < .001).

CONCLUSIONS:

Compared with glargine at 52 weeks, peglispro resulted in a statistically superior reduction in HbA1c, more patients achieving HbA1c targets, less nocturnal hypoglycaemia, no improvement in total hypoglycaemia, higher triglyceride levels, higher aminotransferase levels, and more injection site reactions.

• Authors: M J Davies, D Russell-Jones, J-L Selam, T S Bailey, Z Kerényi, J Luo, J Bue-Valleskey, T Iványi, M L Hartman, J G Jacobson, S J Jacober, IMAGINE 2 Study Investigators
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 18 Issue 11 Pg. 1055-1064 (11 2016) ISSN: 1463-1326 [Electronic] England
• PMID: 27349219 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Chemical References

• Blood Glucose
• Hypoglycemic Agents
• Insulin Lispro
• basal insulin peglispro
• Insulin Glargine
• Polyethylene Glycols

Topics

• Administration, Oral
• Aged
• Blood Glucose (drug effects, metabolism)
• Circadian Rhythm
• Diabetes Mellitus, Type 2 (blood, drug therapy)
• Double-Blind Method
• Drug Therapy, Combination
• Fasting (blood)
• Female
• Humans
• Hypoglycemic Agents (administration & dosage, adverse effects)
• Insulin Glargine (administration & dosage, adverse effects)
• Insulin Lispro (administration & dosage, adverse effects, analogs & derivatives)
• Male
• Middle Aged
• Polyethylene Glycols (administration & dosage, adverse effects)