The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes

Trevor J Orchard, Bertrand Cariou, Margery A Connelly, James D Otvos, Shuyu Zhang, Caryl J Antalis, Tibor Ivanyi, Byron J Hoogwerf, Trevor J Orchard, Bertrand Cariou, Margery A Connelly, James D Otvos, Shuyu Zhang, Caryl J Antalis, Tibor Ivanyi, Byron J Hoogwerf

Abstract

Background: In Phase 2/3 studies of basal insulin peglispro (BIL) compared to insulin glargine, patients with type 1 or type 2 diabetes previously treated with insulin and randomized to BIL had an increase in serum triglycerides (TGs). To further understand lipoprotein changes, a lipid substudy which included liver fat content was designed to assess relationships among the measured variables for each diabetes cohort and compare the hepato-preferential insulin BIL to glargine.

Methods: In three cohorts of patients with diabetes (type 1, type 2 insulin naïve, and type 2 previously on insulin; n = 652), liver fat content (LFC) was determined by magnetic resonance imaging (MRI) and blood lipids were analyzed by nuclear magnetic resonance (NMR) spectroscopy at baseline, 26 and 52 weeks of treatment. Apolipoproteins, adiponectin, and other lipid parameters were also measured. Descriptive statistics were done, as well as correlation analyses to look for relationships among LFC and lipoproteins or other lipid measures.

Results: In patients with type 1 diabetes treated with BIL, but not glargine, small LDL and medium and large VLDL subclass concentrations increased from baseline. In patients with type 2 diabetes previously on insulin and treated with BIL, large VLDL concentration increased from baseline. In insulin naïve patients with type 2 diabetes treated with BIL, there were very few changes, while in those treated with glargine, small LDL and large VLDL decreased from baseline. Baseline LFC correlated significantly in one or more cohorts with baseline large VLDL, small LDL, VLDL size, and Apo C3. Changes in LFC by treatment showed generally weak correlations with lipoprotein changes, except for positive correlations with large VLDL and VLDL size. Adiponectin was higher in patients with type 1 diabetes compared to patients with type 2 diabetes, but decreased with treatment with both BIL and glargine.

Conclusions: The lipoprotein changes were in line with the observed changes in serum TGs; i.e., the cohorts experiencing increased TGs and LFC with BIL treatment had decreased LDL size and increased VLDL size. These data and analyses add to the currently available information on the metabolic effects of insulins in a very carefully characterized cohort of patients with diabetes. Clinicaltrials.gov registration numbers and dates NCT01481779 (2011), NCT01435616 (2011), NCT01454284 (2011), NCT01582451 (2012).

Keywords: Adiponectin; Apolipoproteins; Basal insulin peglispro; Diabetes; Insulin glargine; Lipoproteins; Liver fat; MRI; NMR.

Figures

Fig. 1
Fig. 1
LDL subclass and IDL particle concentratons by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 2

HDL, LDL, and VLDL particle…

Fig. 2

HDL, LDL, and VLDL particle size changes by treatment in three patient cohorts.…

Fig. 2
HDL, LDL, and VLDL particle size changes by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 3

VLDL and VLDL subclass particle…

Fig. 3

VLDL and VLDL subclass particle concentrations by treatment in three patient cohorts. Data…

Fig. 3
VLDL and VLDL subclass particle concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 4

HDL and HDL subclass particle…

Fig. 4

HDL and HDL subclass particle concentrations by treatment in three patient cohorts. Data…

Fig. 4
HDL and HDL subclass particle concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 5

Apolipoprotein concentrations by treatment in…

Fig. 5

Apolipoprotein concentrations by treatment in three patient cohorts. Data are LS mean ±…

Fig. 5
Apolipoprotein concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 6

Adiponectin change from baseline to…

Fig. 6

Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine…

Fig. 6
Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine or BIL. Data are LS mean ± SE; all between treatment differences had p ≥ 0.001. ***p T1D type 1 diabetes, T2D type 2 diabetes, BS basal switch cohort, IN insulin naïve cohort
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References
    1. Chaudhuri A, Rosenstock J, DiGenio A, Meneghini L, Hollander P, McGill JB, Dandona P, Ilgenfritz J, Riddle M. Comparing the effects of insulin glargine and thiazolidinediones on plasma lipids in type 2 diabetes: a patient-level pooled analysis. Diabetes Metab Res Rev. 2012;28(3):258–267. doi: 10.1002/dmrr.1305. - DOI - PMC - PubMed
    1. Chaudhuri A, Dandona P. Effects of insulin and other antihyperglycaemic agents on lipid profiles of patients with diabetes. Diabetes Obes Metab. 2011;13(10):869–879. doi: 10.1111/j.1463-1326.2011.01423.x. - DOI - PubMed
    1. Hansen RJ, Cutler GB, Vick A, Koester A, Li S, Siesky AM, Beals JM. LY2605541: leveraging hydrodynamic size to develop a novel basal insulin. Diabetes. 2012;61(Suppl 1):A228.
    1. Mudaliar S, Henry RR, Ciaraldi TP, Armstrong DA, Burke PM, Pettus JH, Garhyan P, Choi SL, Knadler MP, Lam EC, et al. Reduced peripheral activity leading to hepato-preferential action of basal insulin peglispro compared with insulin glargine in patients with type 1 diabetes. Diabetes Obes Metab. 2016;18(Suppl 2):17–24. doi: 10.1111/dom.12753. - DOI - PubMed
    1. Jacober SJ, Prince MJ, Beals JM, Hartman ML, Qu Y, Linnebjerg H, Garhyan P, Haupt A. Basal insulin peglispro: overview of a novel long-acting insulin with reduced peripheral effect resulting in a hepato-preferential action. Diabetes Obes Metab. 2016;18(Suppl 2):3–16. doi: 10.1111/dom.12744. - DOI - PubMed
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Fig. 2
Fig. 2
HDL, LDL, and VLDL particle size changes by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 3

VLDL and VLDL subclass particle…

Fig. 3

VLDL and VLDL subclass particle concentrations by treatment in three patient cohorts. Data…

Fig. 3
VLDL and VLDL subclass particle concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 4

HDL and HDL subclass particle…

Fig. 4

HDL and HDL subclass particle concentrations by treatment in three patient cohorts. Data…

Fig. 4
HDL and HDL subclass particle concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 5

Apolipoprotein concentrations by treatment in…

Fig. 5

Apolipoprotein concentrations by treatment in three patient cohorts. Data are LS mean ±…

Fig. 5
Apolipoprotein concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 6

Adiponectin change from baseline to…

Fig. 6

Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine…

Fig. 6
Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine or BIL. Data are LS mean ± SE; all between treatment differences had p ≥ 0.001. ***p T1D type 1 diabetes, T2D type 2 diabetes, BS basal switch cohort, IN insulin naïve cohort
Similar articles
Cited by
References
    1. Chaudhuri A, Rosenstock J, DiGenio A, Meneghini L, Hollander P, McGill JB, Dandona P, Ilgenfritz J, Riddle M. Comparing the effects of insulin glargine and thiazolidinediones on plasma lipids in type 2 diabetes: a patient-level pooled analysis. Diabetes Metab Res Rev. 2012;28(3):258–267. doi: 10.1002/dmrr.1305. - DOI - PMC - PubMed
    1. Chaudhuri A, Dandona P. Effects of insulin and other antihyperglycaemic agents on lipid profiles of patients with diabetes. Diabetes Obes Metab. 2011;13(10):869–879. doi: 10.1111/j.1463-1326.2011.01423.x. - DOI - PubMed
    1. Hansen RJ, Cutler GB, Vick A, Koester A, Li S, Siesky AM, Beals JM. LY2605541: leveraging hydrodynamic size to develop a novel basal insulin. Diabetes. 2012;61(Suppl 1):A228.
    1. Mudaliar S, Henry RR, Ciaraldi TP, Armstrong DA, Burke PM, Pettus JH, Garhyan P, Choi SL, Knadler MP, Lam EC, et al. Reduced peripheral activity leading to hepato-preferential action of basal insulin peglispro compared with insulin glargine in patients with type 1 diabetes. Diabetes Obes Metab. 2016;18(Suppl 2):17–24. doi: 10.1111/dom.12753. - DOI - PubMed
    1. Jacober SJ, Prince MJ, Beals JM, Hartman ML, Qu Y, Linnebjerg H, Garhyan P, Haupt A. Basal insulin peglispro: overview of a novel long-acting insulin with reduced peripheral effect resulting in a hepato-preferential action. Diabetes Obes Metab. 2016;18(Suppl 2):3–16. doi: 10.1111/dom.12744. - DOI - PubMed
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Fig. 3
Fig. 3
VLDL and VLDL subclass particle concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 4

HDL and HDL subclass particle…

Fig. 4

HDL and HDL subclass particle concentrations by treatment in three patient cohorts. Data…

Fig. 4
HDL and HDL subclass particle concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 5

Apolipoprotein concentrations by treatment in…

Fig. 5

Apolipoprotein concentrations by treatment in three patient cohorts. Data are LS mean ±…

Fig. 5
Apolipoprotein concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 6

Adiponectin change from baseline to…

Fig. 6

Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine…

Fig. 6
Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine or BIL. Data are LS mean ± SE; all between treatment differences had p ≥ 0.001. ***p T1D type 1 diabetes, T2D type 2 diabetes, BS basal switch cohort, IN insulin naïve cohort
Similar articles
Cited by
References
    1. Chaudhuri A, Rosenstock J, DiGenio A, Meneghini L, Hollander P, McGill JB, Dandona P, Ilgenfritz J, Riddle M. Comparing the effects of insulin glargine and thiazolidinediones on plasma lipids in type 2 diabetes: a patient-level pooled analysis. Diabetes Metab Res Rev. 2012;28(3):258–267. doi: 10.1002/dmrr.1305. - DOI - PMC - PubMed
    1. Chaudhuri A, Dandona P. Effects of insulin and other antihyperglycaemic agents on lipid profiles of patients with diabetes. Diabetes Obes Metab. 2011;13(10):869–879. doi: 10.1111/j.1463-1326.2011.01423.x. - DOI - PubMed
    1. Hansen RJ, Cutler GB, Vick A, Koester A, Li S, Siesky AM, Beals JM. LY2605541: leveraging hydrodynamic size to develop a novel basal insulin. Diabetes. 2012;61(Suppl 1):A228.
    1. Mudaliar S, Henry RR, Ciaraldi TP, Armstrong DA, Burke PM, Pettus JH, Garhyan P, Choi SL, Knadler MP, Lam EC, et al. Reduced peripheral activity leading to hepato-preferential action of basal insulin peglispro compared with insulin glargine in patients with type 1 diabetes. Diabetes Obes Metab. 2016;18(Suppl 2):17–24. doi: 10.1111/dom.12753. - DOI - PubMed
    1. Jacober SJ, Prince MJ, Beals JM, Hartman ML, Qu Y, Linnebjerg H, Garhyan P, Haupt A. Basal insulin peglispro: overview of a novel long-acting insulin with reduced peripheral effect resulting in a hepato-preferential action. Diabetes Obes Metab. 2016;18(Suppl 2):3–16. doi: 10.1111/dom.12744. - DOI - PubMed
Show all 51 references
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Fig. 4
Fig. 4
HDL and HDL subclass particle concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 5

Apolipoprotein concentrations by treatment in…

Fig. 5

Apolipoprotein concentrations by treatment in three patient cohorts. Data are LS mean ±…

Fig. 5
Apolipoprotein concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 6

Adiponectin change from baseline to…

Fig. 6

Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine…

Fig. 6
Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine or BIL. Data are LS mean ± SE; all between treatment differences had p ≥ 0.001. ***p T1D type 1 diabetes, T2D type 2 diabetes, BS basal switch cohort, IN insulin naïve cohort
Similar articles
Cited by
References
    1. Chaudhuri A, Rosenstock J, DiGenio A, Meneghini L, Hollander P, McGill JB, Dandona P, Ilgenfritz J, Riddle M. Comparing the effects of insulin glargine and thiazolidinediones on plasma lipids in type 2 diabetes: a patient-level pooled analysis. Diabetes Metab Res Rev. 2012;28(3):258–267. doi: 10.1002/dmrr.1305. - DOI - PMC - PubMed
    1. Chaudhuri A, Dandona P. Effects of insulin and other antihyperglycaemic agents on lipid profiles of patients with diabetes. Diabetes Obes Metab. 2011;13(10):869–879. doi: 10.1111/j.1463-1326.2011.01423.x. - DOI - PubMed
    1. Hansen RJ, Cutler GB, Vick A, Koester A, Li S, Siesky AM, Beals JM. LY2605541: leveraging hydrodynamic size to develop a novel basal insulin. Diabetes. 2012;61(Suppl 1):A228.
    1. Mudaliar S, Henry RR, Ciaraldi TP, Armstrong DA, Burke PM, Pettus JH, Garhyan P, Choi SL, Knadler MP, Lam EC, et al. Reduced peripheral activity leading to hepato-preferential action of basal insulin peglispro compared with insulin glargine in patients with type 1 diabetes. Diabetes Obes Metab. 2016;18(Suppl 2):17–24. doi: 10.1111/dom.12753. - DOI - PubMed
    1. Jacober SJ, Prince MJ, Beals JM, Hartman ML, Qu Y, Linnebjerg H, Garhyan P, Haupt A. Basal insulin peglispro: overview of a novel long-acting insulin with reduced peripheral effect resulting in a hepato-preferential action. Diabetes Obes Metab. 2016;18(Suppl 2):3–16. doi: 10.1111/dom.12744. - DOI - PubMed
Show all 51 references
Publication types
MeSH terms
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Copy Download .nbib
Format: AMA APA MLA NLM
Fig. 5
Fig. 5
Apolipoprotein concentrations by treatment in three patient cohorts. Data are LS mean ± SE. p values are given for between-treatment differences where p 

Fig. 6

Adiponectin change from baseline to…

Fig. 6

Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine…

Fig. 6
Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine or BIL. Data are LS mean ± SE; all between treatment differences had p ≥ 0.001. ***p T1D type 1 diabetes, T2D type 2 diabetes, BS basal switch cohort, IN insulin naïve cohort
Fig. 6
Fig. 6
Adiponectin change from baseline to 26 and 52 weeks of treatment with glargine or BIL. Data are LS mean ± SE; all between treatment differences had p ≥ 0.001. ***p T1D type 1 diabetes, T2D type 2 diabetes, BS basal switch cohort, IN insulin naïve cohort

References

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    1. Chaudhuri A, Dandona P. Effects of insulin and other antihyperglycaemic agents on lipid profiles of patients with diabetes. Diabetes Obes Metab. 2011;13(10):869–879. doi: 10.1111/j.1463-1326.2011.01423.x.
    1. Hansen RJ, Cutler GB, Vick A, Koester A, Li S, Siesky AM, Beals JM. LY2605541: leveraging hydrodynamic size to develop a novel basal insulin. Diabetes. 2012;61(Suppl 1):A228.
    1. Mudaliar S, Henry RR, Ciaraldi TP, Armstrong DA, Burke PM, Pettus JH, Garhyan P, Choi SL, Knadler MP, Lam EC, et al. Reduced peripheral activity leading to hepato-preferential action of basal insulin peglispro compared with insulin glargine in patients with type 1 diabetes. Diabetes Obes Metab. 2016;18(Suppl 2):17–24. doi: 10.1111/dom.12753.
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