Different effects of basal insulin peglispro and insulin glargine on liver enzymes and liver fat content in patients with type 1 and type 2 diabetes

Diabetes, Obesity and Metabolism

Volumn 18, Issue , 2016, Pages 50-58

  Cusi, K ^a   Sanyal, A J ^b   Zhang, S ^c   Hoogwerf, B J ^c   Chang, A M ^c   Jacober, S J ^c   Bue Valleskey, J M ^c   Higdon, A N ^c   Bastyr, E J ^c,d   Haupt, A ^c   Hartman, Mark L ^c  

^a UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

basal insulin; fatty liver; liver; randomized trial; type 1 diabetes; type 2 diabetes

Indexed keywords

ALANINE AMINOTRANSFERASE; FAT; INSULIN GLARGINE; INSULIN PEGLISPRO; 2,4 THIAZOLIDINEDIONE DERIVATIVE; ANTIDIABETIC AGENT; ASPARTATE AMINOTRANSFERASE; BASAL INSULIN PEGLISPRO; BILIRUBIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN LISPRO; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MACROGOL DERIVATIVE; METFORMIN; PIOGLITAZONE; SULFONYLUREA DERIVATIVE; TRIACYLGLYCEROL;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BILIRUBIN BLOOD LEVEL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFECT; DRUG WITHDRAWAL; FEMALE; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; LABORATORY TEST; LIVER LEVEL; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; NUCLEAR MAGNETIC RESONANCE IMAGING; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; TOXIC HEPATITIS; ADIPOSE TISSUE; AGED; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; COMBINATION DRUG THERAPY; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DIAGNOSTIC IMAGING; GLUCOSE BLOOD LEVEL; HYPOGLYCEMIA; LIVER; METABOLISM; MIDDLE AGED;

ADIPOSE TISSUE; ADULT; AGED; ALANINE TRANSAMINASE; ASPARTATE AMINOTRANSFERASES; BILIRUBIN; BLOOD GLUCOSE; CHOLESTEROL, HDL; CHOLESTEROL, LDL; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG THERAPY, COMBINATION; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN GLARGINE; INSULIN LISPRO; LIVER; MAGNETIC RESONANCE IMAGING; MALE; METFORMIN; MIDDLE AGED; POLYETHYLENE GLYCOLS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SULFONYLUREA COMPOUNDS; THIAZOLIDINEDIONES; TRIGLYCERIDES;

EID: 84990210189     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12751     Document Type: Article

References (38)

1. Duseja A, Chalasani N. Epidemiology and risk factors of nonalcoholic fatty liver disease (NAFLD). Hepatol Int. 2013;7(Suppl. 2):755–764.
2. Llaurado G, Sevastianova K, Sadevirta S, et al. Liver fat content and hepatic insulin sensitivity in overweight patients with type 1 diabetes. J Clin Endocrinol Metab. 2015;100(2):607–616.
3. Portillo-Sanchez P, Bril F, Maximos M, et al. High prevalence of nonalcoholic fatty liver disease in patients with type 2 diabetes mellitus and normal plasma aminotransferase levels. J Clin Endocrinol Metab. 2015;100(6):2231–2238.
4. Clark JM, Brancati FL, Diehl AM. The prevalence and etiology of elevated aminotransferase levels in the United States. Am J Gastroenterol. 2003;98(5):960–967.
5. Juurinen L, Tiikkainen M, Hakkinen AM, Hakkarainen A, Yki-Jarvinen H. Effects of insulin therapy on liver fat content and hepatic insulin sensitivity in patients with type 2 diabetes. Am J Physiol Endocrinol Metab. 2007;292(3):E829–E835.
6. Lingvay I, Raskin P, Szczepaniak LS. Effect of insulin-metformin combination on hepatic steatosis in patients with type 2 diabetes. J Diabetes Complications. 2007;21(3):137–142.
7. Lingvay I, Roe ED, Duong J, Leonard D, Szczepaniak LS. Effect of insulin versus triple oral therapy on the progression of hepatic steatosis in type 2 diabetes. J Invest Med. 2012;60(7):1059–1063.
8. Bi Y, Zhang B, Xu W, et al. Effects of exenatide, insulin, and pioglitazone on liver fat content and body fat distributions in drug-naive subjects with type 2 diabetes. Acta Diabetol. 2014;51(5):865–873.
9. Tang A, Rabasa-Lhoret R, Castel H, et al. Effects of insulin glargine and liraglutide therapy on liver fat as measured by magnetic resonance in patients with type 2 diabetes: a randomized trial. Diabetes Care. 2015;38(7):1339–1346.
10. Sinha VP, Choi SL, Soon DK, et al. Single-dose pharmacokinetics and glucodynamics of the novel, long-acting basal insulin LY2605541 in healthy subjects. J Clin Pharmacol. 2014;54(7):792–799.
11. Sinha VP, Howey DC, Choi SL, Mace KF, Heise T. Steady-state pharmacokinetics and glucodynamics of the novel, long-acting basal insulin LY2605541 dosed once-daily in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2014;16(4):344–350.
12. Henry RR, Mudaliar S, Ciaraldi TP, et al. Basal insulin peglispro demonstrates preferential hepatic versus peripheral action relative to insulin glargine in healthy subjects. Diabetes Care. 2014;37(9):2609–2615.
13. Buse JB, Rodbard HW, Trescoli Serrano C, et al. Randomized clinical trial comparing basal insulin peglispro and insulin glargine in patients with type 2 diabetes previously treated with basal insulin: IMAGINE 5. Diabetes Care. 2016;39(1):92–100.
14. Bergenstal RM, Lunt H, Franek E, et al. A randomized, double-blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 3. Diabetes Obes Metab. 2016;18:1080–1087.
15. Blevins T, Pieber TR, Colon Vega G, et al. Randomized double-blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 2 diabetes: IMAGINE 4. Diabetes Obes Metab. 2016;18:1071–1079.
16. Davies MJ, Russell-Jones D, Selam JL, et al. Basal insulin peglispro vs insulin glargine in insulin-naїve type 2 diabetes: IMAGINE 2 randomized trial. Diabetes Obes Metab. 2016;18:1054–1063.
17. Garg S, Dreyer M, Jinnouchi H, et al. A randomized clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 1. Diabetes Obes Metab. 2016;18(S2):25–33.
18. Rosenstock J, Marre M, Qu Y, et al. Reduced nocturnal hypoglycemia with basal insulin peglispro compared to insulin glargine: pooled analyses of 5 randomized controlled trials. Diabetes Obes Metab. 2016;18:1092–1096.
19. Rosenstock J, Bergenstal RM, Blevins TC, et al. Better glycemic control and weight loss with the novel long-acting basal insulin LY2605541 compared with insulin glargine in type 1 diabetes: a randomized, crossover study. Diabetes Care. 2013;36(3):522–528.
20. Bergenstal RM, Rosenstock J, Arakaki RF, et al. A randomized, controlled study of once-daily LY2605541, a novel long-acting basal insulin, versus insulin glargine in basal insulin-treated patients with type 2 diabetes. Diabetes Care. 2012;35(11):2140–2147.
21. Mashhood A, Railkar R, Yokoo T, et al. Reproducibility of hepatic fat fraction measurement by magnetic resonance imaging. J Magn Reson Imaging. 2013;37(6):1359–1370.
22. Regev A. How to avoid being surprised by hepatotoxicity at the final stages of drug development and approval. Clin Liver Dis. 2013;17(4):749–767.
23. Food and Drug Administration (FDA). Guidance for industry drug-induced liver injury: Premarketing clinical evaluation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf. Accessed May 4, 2016.
24. Szczepaniak LS, Nurenberg P, Leonard D, et al. Magnetic resonance spectroscopy to measure hepatic triglyceride content: prevalence of hepatic steatosis in the general population. Am J Physiol Endocrinol Metab. 2005;288(2):E462–E468.
25. Maximos M, Bril F, Portillo Sanchez P, et al. The role of liver fat and insulin resistance as determinants of plasma aminotransferase elevation in nonalcoholic fatty liver disease. Hepatology. 2015;61(1):153–160.
26. Schreiber I, Buchfelder M, Droste M, et al. Treatment of acromegaly with the GH receptor antagonist pegvisomant in clinical practice: safety and efficacy evaluation from the German Pegvisomant Observational Study. Eur J Endocrinol. 2007;156(1):75–82.
27. Mircera. Summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000739/WC500033672.pdf. Accessed May 4, 2016.
28. Herring R, Jones RH, Russell-Jones DL. Hepatoselectivity and the evolution of insulin. Diabetes Obes Metab. 2014;16(1):1–8.
29. Dimitriadis G, Mitrou P, Lambadiari V, Maratou E, Raptis SA. Insulin effects in muscle and adipose tissue. Diabetes Res Clin Pract. 2011;93(Suppl. 1):S52–S59.
30. Edgerton DS, Lautz M, Scott M, et al. Insulin's direct effects on the liver dominate the control of hepatic glucose production. J Clin Invest. 2006;116(2):521–527.
31. Vatner DF, Majumdar SK, Kumashiro N, et al. Insulin-independent regulation of hepatic triglyceride synthesis by fatty acids. Proc Natl Acad Sci USA. 2015;112(4):1143–1148.
32. Moore MC, Smith MS, Sinha VP, et al. Novel PEGylated basal insulin LY2605541 has a preferential hepatic effect on glucose metabolism. Diabetes. 2014;63(2):494–504.
33. Mudaliar S, Henry R, Ciaraldi T, et al. Reduced peripheral activity leading to hepato-preferential action of basal insulin peglispro compared to insulin glargine in patients with type 1 diabetes. Diabetes Obes Metab. 2016;18(Suppl 2):17–24.
34. Edgerton DS, Moore MC, Winnick JJ, et al. Changes in glucose and fat metabolism in response to the administration of a hepato-preferential insulin analog. Diabetes. 2014;63(11):3946–3954.
35. Ginsberg H, Cariou B, Orchard TJ, et al. Lipid changes during basal insulin peglispro, insulin glargine, or NPH treatment in 6 IMAGINE trials. Diabetes Obes Metab. 2016;18:1088–1091.
36. Cusi K. Role of obesity and lipotoxicity in the development of nonalcoholic steatohepatitis: pathophysiology and clinical implications. Gastroenterology. 2012;142(4):711–725.
37. Lomonaco R, Bril F, Portillo-Sanchez P, et al. Metabolic impact of nonalcoholic steatohepatitis in obese patients with type 2 diabetes. Diabetes Care. 2016;39(4):632–638.
38. Tolman KG, Fonseca V, Dalpiaz A, Tan MH. Spectrum of liver disease in type 2 diabetes and management of patients with diabetes and liver disease. Diabetes Care. 2007;30(3):734–743.