A randomized clinical trial of basal insulin peglispro vs NPH in insulin-naïve patients with type 2 diabetes: the IMAGINE 6 trial

Diabetes, Obesity and Metabolism

Volumn 18, Issue , 2016, Pages 34-42

  Grunberger, G ^a   Chen, L ^b   Rodriguez, A ^c   Tinahones, F J ^d   Jacober, S J ^b   Bue Valleskey, Juliana ^b  

^a Grunberger Diabetes Institute   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c ELI LILLY AND COMPANY   (Spain)

^d HOSPITAL UNIVERSITARIO VIRGEN DE LA VICTORIA   (Spain)

Author keywords

basal insulin peglispro; insulin na ve; NPH; type 2 diabetes

Indexed keywords

ALANINE AMINOTRANSFERASE; GLUCOSE; HEMOGLOBIN A1C; INSULIN ANTIBODY; INSULIN PEGLISPRO; ISOPHANE INSULIN; ORAL ANTIDIABETIC AGENT; TRIACYLGLYCEROL; 2,4 THIAZOLIDINEDIONE DERIVATIVE; ANTIDIABETIC AGENT; BASAL INSULIN PEGLISPRO; BIGUANIDE DERIVATIVE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; INSULIN LISPRO; MACROGOL DERIVATIVE; SULFONYLUREA DERIVATIVE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; EVENING DOSAGE; FEMALE; FOLLOW UP; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INJECTION SITE HYPERTROPHY; INJECTION SITE REACTION; LIPOHYPERTROPHY; MAJOR CLINICAL STUDY; MALE; MORNING DOSAGE; MULTICENTER STUDY; NOCTURNAL HYPOGLYCEMIA; NON INSULIN DEPENDENT DIABETES MELLITUS; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TOXIC HEPATITIS; TRIACYLGLYCEROL BLOOD LEVEL; AGED; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; DIABETES MELLITUS, TYPE 2; DIET RESTRICTION; METABOLISM; MIDDLE AGED;

AGED; ALANINE TRANSAMINASE; BIGUANIDES; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DRUG THERAPY, COMBINATION; FASTING; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN LISPRO; INSULIN, ISOPHANE; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; SULFONYLUREA COMPOUNDS; THIAZOLIDINEDIONES; TRIGLYCERIDES;

EID: 84990211099     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12743     Document Type: Article

References (29)

1. National Institute for Health and Care Excellence. NICE Clinical Guidance. Type 2 Diabetes: the Management of Type 2 Diabetes. National Institute for Health and Care Excellence; 2016. https://www.nice.org.uk/guidance/ng28 Accessed August 1, 2016.
2. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6):1364–1379.
3. Turner RC, Cull CA, Frighi V, Holman RR, for the UKPDS Group. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999;281(21):2005–2012.
4. UKPDS Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352(9131):837–853.
5. Stark Casagrande S, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988–2010. Diabetes Care. 2013;36(8):2271–2279.
6. Rossetti P, Ampudia-Blasco FJ, Ascaso JF. Old and new basal insulin formulations: understanding pharmacodynamics is still relevant in clinical practice. Diabetes Obes Metab. 2014;16(8):695–706.
7. Riddle MC, Rosenstock J, Gerich J. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003;26(11):3080–3086.
8. Hermansen K, Davies M, Derezinski T, et al. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naïve people with type 2 diabetes. Diabetes Care. 2006;29(6):1269–1274.
9. Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia. 2006;49(3):442–451.
10. Garber AJ. Treat-to-target trials: uses, interpretation and review of concepts. Diabetes Obes Metab. 2014;16(3):193–205.
11. Beals J, Cutler G, Doyle B, et al. PEGylated Insulin lispro compounds. PEGylated insulin lispro compounds. United States patent US 2009/0312236 A1; 2009.
12. 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.
13. 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.
14. Davies MJ, Russell-Jones D, Selam J-L, et al. Basal insulin peglispro vs insulin glargine in insulin-naïve type 2 diabetes: IMAGINE 2 randomized trial. Diabetes Obes Metab. 2016;18:1054–1063.
15. World Health Organization. Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia. 2006. http://www.who.int/diabetes/publications/Definition%20and%20diagnosis%20of%20diabetes_new.pdf. Accessed May 12, 2015.
16. Dmitrienko A, Tamhane AC, Wiens BL. General multistage gatekeeping procedures. Biom J Biometrische Zeitschrift. 2008;50(5):667–677.
17. U.S. Department of Health and Human Services Food and Drug Administration. Guidance for industry drug-induced liver injury: premarketing clinical evaluation. 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf. Accessed May 12, 2015.
18. Buse JB, Rodbard HW, Trescoli Serrano C, et al. A randomized clinical trial comparing basal insulin peglispro and insulin glargine in patients with type 2 diabetes mellitus previously treated with basal insulin: IMAGINE 5. Diabetes Care. 2016;39(1):92–100.
19. Blevins T, Pieber TR, Vega GC, 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.
20. Karl DM, Gill J, Zhou R, Riddle MC. Clinical predictors of risk of hypoglycaemia during addition and titration of insulin glargine for type 2 diabetes mellitus. Diabetes Obes Metab. 2013;15(7):622–628.
21. Ross SA, Tildesley HD, Ashkenas J. Barriers to effective insulin treatment: the persistence of poor glycemic control in type 2 diabetes. Curr Med Res Opin. 2011;27(S3):13–20.
22. 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.
23. 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.
24. 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.
25. 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.
26. Morrow LA, Hompesch M, Jacober SJ, et al. Glucodynamics of longacting basal insulin peglispro (BIL) compared with insulin glargine at steady state in subjects with type 1 diabetes: substudy of a randomized crossover trial. Diabetes Obes Metab. 2016;18:1064–1070.
27. Bergenstal RM, Lincoff AM, Rodriguez A, et al. No difference in major adverse cardiovascular events (MACE+) with basal insulin peglispro (BIL) vs comparator insulins in patients with type 1 or type 2 diabetes. Diabetologia. 2015;58(Suppl 1):S65–S66 [132].
28. 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.
29. Cusi K, Sanyal A, Zhang S, et al. 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 Obes Metab. 2016;18(Suppl 2):50–58.