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ONLINE LETTERS fat content by magnetic resonance imaging, & Johnson, Medtronic, ResMed, Roche COMMENTS AND plasma lipoprotein subclass particle con- Pharmaceuticals, Sanofi, Takeda Pharma- RESPONSES centration (nmol/L), and particle size ceutical Company, Valeritas, and Becton, measured by nuclear magnetic resonance, Dickinson and Company; has received re- total cholesterol efflux capacity, free fatty search support from Abbott Diabetes Care, Amylin Pharmaceuticals, Bayer HealthCare, acids, cholesterylester transfer protein ac- Response to Boehringer Ingelheim Pharmaceuticals, Calibra tivity and mass, adiponectin, and apolipo- Medical, Dexcom, Eli Lilly and Company, Comment on: proteins (Apo-A1, Apo-A2, Apo-B100, and Halozyme Therapeutics, Helmsley Trust, Bergenstal et al. A Apo-CIII). Although high-sensitivity Hygieia, Intarcia Therapeutics, Johnson & C-reactive protein would provide some in- Johnson, MannKind Corporation, Medtronic, Randomized, formation regarding inflammation, the National Institutes of Health, ResMed, Roche Controlled Study of determination of hepatic fat content was Pharmaceuticals, Sanofi, Takeda Pharmaceu- considered to be a fundamental investiga- tical Company, and Becton, Dickinson and Once-Daily Company; and holds stock in Merck & Co. tion. The subsequent effects on insulin fi LY2605541, a sensitivity along with determining inflam- J.R. has served on scienti c advisory panels for Roche Pharmaceuticals, Sanofi, Novo Novel Long-Acting mation were considered to be secondary. Nordisk, Eli Lilly and Company, MannKind Basal Insulin, Lastly, because these patients were treated Corporation, GlaxoSmithKline, Takeda with exogenous insulin prestudy, and cir- Pharmaceutical Company, Daiichi-Sankyo, Versus Insulin culating levels of LY2605541 (similar to Johnson & Johnson, Novartis Pharmaceuti- Glargine in Basal insulin detemir) are very different than cals Corporation, Boehringer Ingelheim – that of human insulin, we question the val- Pharmaceuticals, Lexicon Pharmaceuticals; Insulin Treated idity of the homeostasis model assessment has served as a consultant to Roche Pharma- Patients With Type 2 calculations under these circumstances. ceuticals, Sanofi, Novo Nordisk, Eli Lilly and Company, MannKind Corporation, Glaxo- Diabetes. Diabetes SmithKline, Takeda Pharmaceutical Company, 1 Care 2012;35: RICHARD M. BERGENSTAL, MD Daiichi-Sankyo, Johnson & Johnson, Novartis 2 – JULIO ROSENSTOCK, MD Pharmaceuticals Corporation, Boehringer Ingel- 2140 2147 3 RICHARD F. ARAKAKI, MD heim Pharmaceuticals, and Lexicon Pharma- 4 ceuticals; and has received research support MELVIN J. PRINCE, MD 4 from Pfizer, Sanofi, Novo Nordisk, Roche YONGMING QU, PHD 4 Pharmaceuticals, Bristol-Myers Squibb Com- e thank Professor Home for his VIKRAM P. SINHA, PHD interest (1) in our publication 4 pany, Eli Lilly and Company, Forest Laborato- W DANIEL C. HOWEY, MD ries, GlaxoSmithKline, Takeda Pharmaceutical on a novel basal insulin analog, 4 SCOTT J. JACOBER, DO Company, Novartis Pharmaceuticals Corpo- LY2605541 (2). 1 ration, AstraZeneca LP, Amylin Pharmaceuti- Total, LDL, and HDL cholesterol From the International Diabetes Center at Park cals, Johnson & Johnson, Daiichi-Sankyo, Nicollet, Minneapolis, Minnesota; the 2Dallas levels along with triglyceride levels (or MannKind Corporation, Lexicon Phar- fi Diabetes and Endocrine Center at Medical City, lipid pro les) were measured as noted Dallas, Texas; the 3University of Hawaii at Manoa, maceuticals, and Boehringer Ingelheim in the last paragraph on page 2144 (2). Honolulu, Hawaii; and 4Eli Lilly and Company, Pharmaceuticals. R.F.A. has been a consultant Whereas the serum triglyceride mea- Indianapolis, Indiana. to Novo Nordisk and Sanofi; has received re- Corresponding author: Scott J. Jacober, jacober_scott_j@ search support from Eli Lilly and Company, surements for the LY2605541-treated fi patients did not differ from baseline lilly.com. Sano ,NovoNordisk,NovartisPharmaceu- DOI: 10.2337/dc13-0295 ticals Corporation, AstraZeneca LP, and Reata but were higher compared with insulin V.P.S. is currently affiliated with the U.S. Food and – Pharmaceuticals; and has participated in glargine treated patients, the total, HDL, Drug Administration, Silver Spring, Maryland. Speaker’s Bureaus for Amylin Pharmaceuticals and LDL cholesterol did not differ from The opinions expressed in this article are those of the authors and do not necessarily reflect the and Eli Lilly and Company. M.J.P., Y.Q., and baseline for the LY2605541-treated pa- views of the U.S. Food and Drug Adminstration. S.J.J. are employees of and hold stock in Eli tients and did not differ from those treated © 2013 by the American Diabetes Association. Lilly and Company. D.C.H. is a retired em- with insulin glargine. In contrast, in the Readers may use this article as long as the work is ployee of Eli Lilly and Company and holds recently published type 1 diabetes study properly cited, the use is educational and not for stock in Eli Lilly and Company. V.P.S. is a profit, and the work is not altered. See http:// (3), LY2605541-treated patients demon- past employee and is currently a stock holder creativecommons.org/licenses/by-nc-nd/3.0/ for of Eli Lilly and Company. No other potential strated a modest increase in triglycerides details. conflicts of interest relevant to this article were and LDL cholesterol compared with base- reported. line and to insulin glargine-treated pa- tients, whereas the HDL cholesterol with Acknowledgments—R.M.B. has served on cccccccccccccccccccccccc LY2605541 decreased from baseline and scientific advisory panels for Abbott Diabe- compared with insulin glargine. As these tes Care, Amylin Pharmaceuticals, Bayer References findings were first noted in these explor- HealthCare, Eli Lilly and Company, Hygieia, 1. Home PD. Comment on: Bergenstal et al. atory phase 2 studies, the phase 3 studies Johnson & Johnson, Roche Pharmaceuticals, A randomized, controlled study of once- will measure routine lipids and hepatic Sanofi, and Valeritas; has served as a consul- daily LY2605541, a novel long-acting basal tant to Abbott Diabetes Care, Amylin Phar- insulin, versus insulin glargine in basal transaminase levels at frequent intervals maceuticals, Bayer HealthCare, Boehringer insulin–treated patients with type 2 diabe- to characterize the chronology of these Ingelheim Pharmaceuticals, Calibra Medi- tes. Diabetes Care 2012;35:2140–2147 changes. Additionally, in a subset of pa- cal, Eli Lilly and Company, Halozyme Ther- (Letter). Diabetes Care 2013;36:e106. tients, these studies will measure hepatic apeutics, Helmsley Trust, Hygieia, Johnson DOI: 10.2337/dc13-0038 care.diabetesjournals.org DIABETES CARE, VOLUME 36, JULY 2013 e107 Online Letters 2. Bergenstal RM, Rosenstock J, Arakaki RF, insulin-treated patients with type 2 diabetes. loss with the novel long-acting basal insulin et al. A randomized, controlled study of Diabetes Care 2012;35:2140–2147 LY2605541 compared with insulin glargine once-daily LY2605541, a novel long-acting 3. Rosenstock J, Bergenstal RM, Blevins TC, in type 1 diabetes: a randomized, crossover basal insulin, versus insulin glargine in basal et al. Better glycemic control and weight study. Diabetes Care 2013;36:522–528 e108 DIABETES CARE, VOLUME 36, JULY 2013 care.diabetesjournals.org.