Basal insulin peglispro versus insulin glargine in insulin-naïve type 2 diabetes

IMAGINE 2 randomized trial

for the IMAGINE 2 Study Investigators

Research output: Article

24 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1055-1064
Number of pages10
JournalDiabetes, Obesity and Metabolism
Volume18
Issue number11
DOIs
Publication statusPublished - nov. 1 2016

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Type 2 Diabetes Mellitus
Hypoglycemia
Insulin
Confidence Intervals
Least-Squares Analysis
Triglycerides
Fats
Odds Ratio
Injections
Liver
Glycosylated Hemoglobin A
Aspartate Aminotransferases
Transaminases
Alanine Transaminase
Hypoglycemic Agents
Aspartic Acid
Insulin Glargine
Safety
Glucose
Serum

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Basal insulin peglispro versus insulin glargine in insulin-naïve type 2 diabetes : IMAGINE 2 randomized trial. / for the IMAGINE 2 Study Investigators.

In: Diabetes, Obesity and Metabolism, Vol. 18, No. 11, 01.11.2016, p. 1055-1064.

Research output: Article

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title = "Basal insulin peglispro versus insulin glargine in insulin-na{\"i}ve 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-na{\"i}ve 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.",
keywords = "basal insulin peglispro, BIL, insulin therapy, insulin-na{\"i}ve, type 2 diabetes",
author = "{for the IMAGINE 2 Study Investigators} and Davies, {M. J.} and D. Russell-Jones and Selam, {J. L.} and Bailey, {T. S.} and Z. Ker{\'e}nyi and J. Luo and J. Bue-Valleskey and T. Iv{\'a}nyi and Hartman, {M. L.} and Jacobson, {J. G.} and Jacober, {S. J.}",
year = "2016",
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language = "English",
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T1 - Basal insulin peglispro versus insulin glargine in insulin-naïve type 2 diabetes

T2 - IMAGINE 2 randomized trial

AU - for the IMAGINE 2 Study Investigators

AU - Davies, M. J.

AU - Russell-Jones, D.

AU - Selam, J. L.

AU - Bailey, T. S.

AU - Kerényi, Z.

AU - Luo, J.

AU - Bue-Valleskey, J.

AU - Iványi, T.

AU - Hartman, M. L.

AU - Jacobson, J. G.

AU - Jacober, S. J.

PY - 2016/11/1

Y1 - 2016/11/1

N2 - 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.

AB - 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.

KW - basal insulin peglispro

KW - BIL

KW - insulin therapy

KW - insulin-naïve

KW - type 2 diabetes

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