Attenuated Efficacy of Dulaglutide in Elder Type 2 Diabetes Mellitus (T2DM) Cases
DOI:
https://doi.org/10.17140/DROJ-4-136Keywords:
Dulaglutide Glucagon-like peptide-1 (GLP-1), Incretin Type 2 diabetes mellitus (T2DM), C-peptide index (CPI) Basal supported oral therapy (BOT).Abstract
Acute increase of type 2 diabetes mellitus (T2DM) is a serious medical problem. Recently, an agent known as Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) was developed for T2DM which has remarkable efficacy and safety profile. In this article, we reported 2 T2DM cases with dulaglutide treatment, showing interesting clinical course. Case 1 is an 88-year-old man with hypertension, arteriosclerosis and mild cognitive impairment (MCI) without difficulties of Quality of Life (QOL)/Activities in Daily living (ADL) in daily life. He has been rather stable on liraglutide with HbA1c 7.2%. After switching from liraglutide to dulaglutide, HbA1c decreased to 6.7% in 2 months, but later increased to 11.3% in 3 months. C-peptide index (CPI) decreased from 2.5 to 0.8. Case 2 is an 83-year-old man and was treated by degludec with CPI 1.35. After switching to dulaglutide, HbA1c decreased to 7.6% in 2 months, but later increased to 10.3% in 2 months. These two cases revealed similar clinical course. Some possibilities might be speculated, including antibody production, differences of GLP-1 RAs from man-origin or lizard-origin, changes in body weight, a possible complication of renal, hepatic inflammatory influences and the subacute decreased ability of insulin secretion in the β cells. The current report would be useful for treatment of GLP-1 RAs in the future.
References
International Diabetes Federation (IDF). Standards of medical care in diabetes-2015. Diabetes Care. 2015; 38: S1-S94. doi: 10.2337/ dc15-S002
Diabetes Atlas 2014 Update. Brussels, Belgium: International Diabetes Federation; 2014.
Defronzo RA. Banting Lecture. From the triumvirate to the om-inous octet: A new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009; 58: 773-795. doi: 10.2337/db09-9028
Forbes JM, Cooper ME. Mechanisms of diabetic complications. Physiol Rev. 2013; 93: 137-188. doi: 10.1152/physrev.00045.2011
Einarson TR, Garg M, Kaur V, Hemels ME. Composite end-points in trials of type-2 diabetes. Diabetes Obes Metab. 2014; 16: 492-499. doi: 10.1111/dom.12226
Elrick H, Stimmler L, Hlad CJ Jr, Arai Y. Plasma insulin re-sponse to oral and intravenous glucose administration. J Clin Endo-crinol Metab. 1964; 24: 1076-1082. doi: 10.1210/jcem-24-10-1076
Kreymann B, Williams G, Ghatei MA, Bloom SR. Glucagon-like peptide-1 7-36: A physiological incretin in man. Lancet. 1987; 2(8571): 1300-1304. doi: 10.1016/S0140-6736(87)91194-9
Smith EP, An Z, Wagner C, et al. The role of β cell glucagon-like peptide-1 signaling in glucose regulation and response to di-abetes drugs. Cell Metab. 2014; 19(6): 1050-1057. doi: 10.1016/j. cmet.2014.04.005
Yabe D, Seino Y. Defining the role of GLP-1 receptor agonists for individualized treatment of type 2 diabetes. Expet Rev Endocrinol Metabol. 2014; 9: 659-670. doi: 10.1586/17446651.2014.949672
Drucker DJ. Incretin action in the pancreas: Potential promise, possible perils, and pathological pitfalls. Diabetes 2013; 62: 3316- 3323. doi: 10.2337/db13-0822
Seino Y, Yabe D. Glucose-dependent insulinotropic polypep-tide and glucagon-like peptide-1: Incretin actions beyond the pan-creas. J Diabetes Investig. 2013; 4: 108-130. doi: 10.1111/jdi.12065
BandoH, Ebe K, Muneta T, Bando M, Yonei Y. Investigation of uric acid and cystatin C on low-carbohydrate diet (LCD). Diabe-tes Res Open J. 2017; 3(2): 31-38. doi: 10.17140/DROJ-3-133
Ebe K, Bando H, Muneta T, Bando M, Yonei Y. Effect of low carbohydrate diet (LCD) for diabetic patients with hypertriglyce-mia. Endocrinol Metab. 2017; 1(1): 104.
Muneta T, Kawaguchi E, Nagai Y, et al. Ketone body elevation in placenta, umbilical cord, newborn and mother in normal deli-very. Glycative Stress Research. 2016; 3(3): 133-140.
Bando H, Ebe K, Manabe T, Bando M, Yonei Y. Less carbo-hydrate intake increases serum ketone bodies in low carbohydrate diet. Endocrinol Metab. 2018; 2(1): 9.
Ebe K, Bando H, Yamamoto K, Bando M, Yonei Y. Daily car-bohydrate intake correlates with HbA1c in low carbohydrate diet (LCD). J Diabetol. 2018; 1(1): 4-9.
Yabe D, Seino Y. Two incretin hormones GLP-1 and GIP: Comparison of their actions in insulin secretion and beta cell pres-ervation. Progr Biophys Mol Biol. 2011; 107: 248-256. doi: 10.1016/j. pbiomolbio.2011.07.010
Secher A, Jelsing J, Baquero AF, et al. The arcuate nucleus me-Case Report | Volume 4 | Number 1| Abe T, et al diates GLP-1 receptor agonist liraglutide-dependent weight loss. J Clin Invest. 2014; 124: 4473-4488. doi: 10.1172/JCI75276
Sisley S, Gutierrez-Aguilar R, Scott M, et al. Neuronal GLP1R mediates liraglutide’s anorectic but not glucose-lowering effect. J Clin Invest. 2014; 124: 2456-2463. doi: 10.1172/JCI72434
Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exena-tide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014; 37(8): 2159-2167. doi: 10.2337/dc13-2760
Glaesner W, Vick AM, Millican R, et al. Engineering and char-acterization of the long-acting glucagonlike peptide-1 analogue LY2189265, an Fc fusion protein. Diabetes Metab Res Rev. 2010; 26: 287-296. doi: 10.1002/dmrr.1080
Terauchi Y, Satoi Y, Takeuchi M, Imaoka T. Monotherapy with the once weekly GLP-1 receptor agonist dulaglutide for 12 weeks in Japanese patients with type 2 diabetes: Dose-dependent effects on glycaemic control in a randomised, double-blind, place-bo-controlled study. Endocr J. 2014; 61(10): 949-959. doi: 10.1507/ endocrj.EJ14-0147
Gurung T, Shyangdan DS, O’Hare JP, Waugh N. A novel, long-acting glucagon-like peptide receptor-agonist: Dulaglutide. Diabetes Metab Syndr Obes. 2015; 10; 8: 363-86. doi: 10.2147/DMSO.S34418
Skrivanek Z, Gaydos BL, Chien JY, et al. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014; 16(8): 748-756. doi: 10.1111/dom.12305
Onishi Y, Oura T, Nishiyama H, Ohyama S, Takeuchi M, Iwa-moto N. Subgroup analysis of phase 3 studies of dulaglutide in Japanese patients with type 2 diabetes. Endocr J. 2016; 63(3): 263- 273. doi: 10.1507/endocrj.EJ15-0518
Hamano K, Nishiyama H, Matsui A, Sato M, Takeuchi M. Ef-ficacy and safety analyses across 4 subgroups combining low and high age and body mass index groups in Japanese phase 3 studies of dulaglutide 0.75 mg after 26 weeks of treatment. Endocr J. 2017; 64(4): 449-456. doi: 10.1507/endocrj.EJ16-0428
Emoto M, Terauchi Y, Ozeki A, Oura T, Takeuchi M, Imaoka T. A 1-year safety study of dulaglutide in Japanese patients with type 2 diabetes on a single oral hypoglycemic agent: an open-label, nonrandomized, phase 3 trial. Endocr J. 2015; 62(12): 1101-1114. doi: 10.1507/endocrj.EJ15-0401
Araki E, Inagaki N, Tanizawa Y, Oura T, Takeuchi M, Imaoka T. Efficacy and safety of once-weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once-daily insulin glargine in Japanese patients with type 2 diabetes: A ran-domized, open-label, phase III, non-inferiority study. Diabetes Obes Metab. 2015; 17(10): 994-1002. doi: 10.1111/dom.12540
Tuttle KR, McKinney TD, Davidson JA, Anglin G, Harper KD, Botros FT. Effects of once-weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clini-cal trials. Diabetes Obes Metab. 2017; 19(3): 436-441. doi: 10.1111/ dom.12816
Yabe D, Seino Y. Defining the role of GLP-1 receptor agonists for individualized treatment of type 2 diabetes. Expet Rev Endocrinol Metabol. 2014; 9: 659-670. doi: 10.1586/17446651.2014.949672
Meier JJ. GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2012; 8: 728-742. doi: 10.1038/nrendo.2012.140
Kuwata H, Iwasaki M, Shimizu S, Minami K, Maeda H, Sei-no S. Meal sequence and glucose excursion, gastric emptying and incretin secretion in type 2 diabetes: A randomised, controlled crossover, exploratory trial. Diabetologia. 2016; 59(3): 453-461. doi: 10.1007/s00125-015-3841-z
Yabe D, Kuwata H, Usui R, Kurose T, Seino Y. Glucagon-like peptide-1 receptor agonist therapeutics for total diabetes manage-ment: Assessment of composite end-points. Curr Med Res Opin. 2015; 31(7): 1267-1270. doi: 10.1185/03007995.2015.1045471
Davies MJ, Kela R, Khunti K. Liraglutide. Overview of the pre-clinical and clinical data and its role in the treatment of type 2 dia-betes. Diabetes Obes Metab. 2011; 13: 207-220. doi: 10.1111/j.1463- 1326.2010.01330.x
King AB, Montanya E, Pratley RE, et al. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C 58.0%. Endocr Pract. 2013; 19: 64-72. doi: 10.4158/EP12232.OR
Langer J, Hunt B, Valentine WJ. Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States. J Manag Care Pharm. 2013; 19: 237-246. doi: 10.18553/ jmcp.2013.19.3.237
Brady EM, Davies MJ, Gray LJ, et al. A randomized controlled trial comparing the GLP-1 receptor agonist liraglutide to a sulpho-nylurea as add on to metformin in patients with established type 2 diabetes during Ramadan: The Treat 4 Ramadan Trial. Diabetes Obes Metab. 2014; 16: 527-536. doi: 10.1111/dom.12249
Li CJ, Li J, Zhang QM, et al. Efficacy and safety comparison between liraglutide as add-on therapy to insulin and insulin dose-increase in Chinese subjects with poorly controlled type 2 diabetes and abdominal obesity. Cardiovasc Diabetol. 2012; 11: 142-149. doi: 10.1186/1475-2840-11-142
Pratley RE, Nauck MA, Barnett AH, et al. Once-weekly al-biglutide versus once daily liraglutide in patients with type 2 dia-betes inadequately controlled on oral drugs (HARMONY 7): A randomised, open-label, multicentre, non-inferiority phase 3 study. Submit your article to this journal | https://openventio.org/submit-manuscript/ Lancet Diabetes Endocrinol. 2014; 2: 289-297. doi: 10.1186/1475- 2840-11-142
Dungan KM, Povedano ST, Forst T, et al. Once-weekly dula-glutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): A randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014; 84: 1349-1357. doi: 10.1016/ S0140-6736(14)60976-4
Miyagawa J, Odawara M, Takamura T, Iwamoto N, Takita Y, Imaoka. Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide is non-inferior to once-daily liraglutide and superior to placebo in Japanese patients with type 2 diabetes: A 26-week randomized phase III study. Diabetes Obes Metab. 2015; 17(10): 974- 983. doi: 10.1111/dom.12534
Odawara M, Miyagawa J, Iwamoto N, Takita Y, Imaoka T, Takamura T. Once-weekly glucagon-like peptide-1 receptor ago-nist dulaglutide significantly decreases glycated haemoglobin com-pared with once-daily liraglutide in Japanese patients with type 2 diabetes: 52 weeks of treatment in a randomized phase III study. Diabetes Obes Metab. 2016; 18(3): 249-257. doi: 10.1111/dom.12602
Pozzilli P, Norwood P, Jódar E, et al. Placebo-controlled, ran-domized trial of the addition of once-weekly glucagon-like pep-tide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab. 2017; 19(7): 1024-1031. doi: 10.1111/dom.12937
Lingvay I, Pérez Manghi F, García-Hernández P, et al. DUAL V Investigators. Effect of insulin glargine up-titration vs insulin de-gludec/ liraglutide on glycated hemoglobin levels in patients with uncontrolled type 2 diabetes: The DUAL V Randomized Clinical Trial. JAMA. 2016; 315(9): 898-907. doi: 10.1001/jama.2016.1252
Balena R, Hensley IE, Miller S, Barnett AH. Combination ther-apy with GLP-1 receptor agonists and basal insulin: A systematic review of the literature. Diabetes Obes Metab. 2013; 15: 485-502. doi: 10.1111/dom.12025
Eng C, Kramer CK, Zinman B, Retnakaran R. Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: A systematic review and meta-analysis. Lancet. 2014; 384: 2228-2234. doi: 10.1016/S0140- 6736(14)61335-0
Usui R, Yabe D, Kuwata H, et al. Retrospective analysis of safety and efficacy of insulin-to-liraglutide switch in Japanese type 2 diabetes: A caution against inappropriate use in patients with reduced beta cell function. J Diabet Invest. 2013; 4: 585-594. doi: 10.1111/jdi.12111
Yabe D, Ambos A, Cariou B, et al. Adjunctive lixisenatide treatment improves glycemic control in patients with T2DM irre-spective of b-cell function. Diabetes. 2014; 64(Suppl 1): A253. doi: 10.1016/j.jcjd.2014.07.138
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