Dulaglutide in the treatment of adult type 2 diabetes: a perspective for primary care providers

Postgraduate Medicine

Volumn 128, Issue 8, 2016, Pages 810-821

  Anderson, John E ^a   Thieu, Vivian T ^b   Boye, Kristina S ^b   Hietpas, Ryan T ^b   Garcia Perez, Luis Emilio ^b  

^a Frist Clinic   (United States)

^b ELI LILLY AND COMPANY   (United States)

Author keywords

diabetes; Dulaglutide; efficacy; GLP 1 receptor agonist; incretin; patient preference; patient reported outcomes; safety

Indexed keywords

DRUG ANTIBODY; DULAGLUTIDE; EXENDIN 4; GLITAZONE DERIVATIVE; GLUCOSE; HEMOGLOBIN A1C; INSULIN GLARGINE; LIRAGLUTIDE; METFORMIN; PLACEBO; SITAGLIPTIN; SULFONYLUREA; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT;

ABNORMAL BLOOD PRESSURE; ADD ON THERAPY; COMORBIDITY; DIARRHEA; DISEASE COURSE; DISEASE DURATION; DRUG DELIVERY DEVICE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; GLYCEMIC CONTROL; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; IMMUNOGENICITY; INCIDENCE; MEDICATION COMPLIANCE; META ANALYSIS (TOPIC); NAUSEA AND VOMITING; NON INSULIN DEPENDENT DIABETES MELLITUS; OBESITY; PATIENT PREFERENCE; PATIENT SATISFACTION; PATIENT-REPORTED OUTCOME; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIMARY HEALTH CARE; REVIEW; TREATMENT OUTCOME; WEIGHT CHANGE; WEIGHT REDUCTION; ANALOGS AND DERIVATIVES; BODY WEIGHT; CHEMICALLY INDUCED; COMBINATION DRUG THERAPY; DEVICES; DIABETES MELLITUS, TYPE 2; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; SUBCUTANEOUS DRUG ADMINISTRATION;

BLOOD GLUCOSE; BODY WEIGHT; CLINICAL TRIALS, PHASE III AS TOPIC; DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; GLUCAGON-LIKE PEPTIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; INJECTIONS, SUBCUTANEOUS; PATIENT REPORTED OUTCOME MEASURES; PRIMARY HEALTH CARE; RECOMBINANT FUSION PROTEINS;

EID: 84981736340     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.1080/00325481.2016.1218260     Document Type: Review

References (48)

1. R.A.DefronzoBanting Lecture. From the triumvirate to the ominous octet:a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58:773–795. doi:10.2337/db09-9028.
2. I.M.Stratton, A.I.Adler, H.A.Neil, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35):prospective observational study. BMJ. 2000;321:405–412.
3. L.M.Siminerio, L.M.Siminerio, S.R.Drab, et al. Diabetes educators:implementing the chronic care model. Diabetes Educ. 2008;34:451–456. doi:10.1177/0145721708316627.
4. Action to Control Cardiovascular Risk in Diabetes Study Group, H.C.Gerstein, M.E.Miller, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358:2545–2559. doi:10.1056/NEJMoa0802743. Action to Control Cardiovascular Risk in Diabetes Study Group.
5. ADVANCE Collaborative Group. A.Patel, S.MacMahon, J.Chalmers, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008;358:2560–2572. doi:10.1056/NEJMoa0802987.
6. W.Duckworth, C.Abraira, T.Moritz, et al. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009;360:129–139. doi:10.1056/NEJMoa0808431. VADT Investigators.
7. International Expert Committee. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care. 2009;32:1327–1334. doi:10.2337/dc09-9033.
8. S.E.Inzucchi, R.M.Bergenstal, J.B.Buse, et al. Management of hyperglycemia in type 2 diabetes, 2015:a patient-centered approach:update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38:140–149. doi:10.2337/dc14-2441.
9. A.J.Garber, M.J.Abrahamson, J.I.Barzilay, et al. Aace/Ace comprehensive diabetes management algorithm 2015. Endocr Practice:Official Journal Am Coll Endocrinol Am Assoc Clin Endocrinologists. 2015;21:438–447. doi:10.4158/EP15693.CS.
10. International Diabetes Federation Guideline Development Group. Global guideline for type 2 diabetes. Diabetes Res Clin Pract. 2014;104:1–52. doi:10.1016/j.diabres.2012.10.001.
11. GLUCOPHAGE and GLUCOPHAGE XR [Prescribing Information]. Princeton (NY):Bristol-Myers Squibb Company; 2009.
12. D.J.Drucker, M.A.Nauck The incretin system:glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 2006;368:1696–1705. doi:10.1016/S0140-6736(06)69705-5.
13. B.Kreymann, G.Williams, M.A.Ghatei, et al. Glucagon-like peptide-1 7-36:a physiological incretin in man. Lancet. 1987;2:1300–1304.
14. R.Ritzel, C.Orskov, J.J.Holst, et al. Pharmacokinetic, insulinotropic, and glucagonostatic properties of GLP-1 [7-36 amide] after subcutaneous injection in healthy volunteers. Dose-response-relationships. Diabetologia. 1995;38:720–725.
15. E.Naslund, M.Gutniak, S.Skogar, et al. Glucagon-like peptide 1 increases the period of postprandial satiety and slows gastric emptying in obese men. Am J Clin Nutr. 1998;68:525–530.
16. A.Wettergren, B.Schjoldager, P.E.Mortensen, et al. Truncated GLP-1 (proglucagon 78-107-amide) inhibits gastric and pancreatic functions in man. Dig Dis Sci. 1993;38:665–673.
17. E.Näslund, B.Barkeling, N.King, et al. Energy intake and appetite are suppressed by glucagon-like peptide-1 (GLP-1) in obese men. International Journal of Obesity and Related Metabolic Disorders:Journal of the International Association for the Study of Obesity. 1999;23:304–311.
18. C.F.Deacon, M.A.Nauck, M.Toft-Nielsen, et al. Both subcutaneously and intravenously administered glucagon-like peptide I are rapidly degraded from the NH2-terminus in type II diabetic patients and in healthy subjects. Diabetes. 1995;44:1126–1131.
19. C.F.Deacon. Circulation and degradation of GIP and GLP-1. Hormone and Metabolic Research. 2004;36:761–765. doi:10.1055/s-2004-826160.
20. W.Glaesner, A.M.Vick, R.Millican, et al. Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein. Diabetes Metab Res Rev. 2010;26:287–296. doi:10.1002/dmrr.1080.
21. J.S.Geiser, Heathman MA, Cui X, et al. Clinical pharmacokinetics of dulaglutide in patients with type 2 diabetes:analyses of data from clinical trials. Clin Pharmacokinet. 2016;55(5):625–634. doi:10.1007/s40262-015-0338-3.
22. Trulicity [Prescribing Information]. Indianapolis (IN):Lilly USA, LLC; 2014.
23. L.Kuritzky, G.Umpierrez, J.M.Ekoé, et al. Safety and efficacy of dulaglutide, a once weekly GLP-1 receptor agonist, for the management of type 2 diabetes. Postgrad Med. 2014;126:60–72. doi:10.3810/pgm.2014.10.2821.
24. L.S.Matza, S.E.Curtis, J.B.Jordan, et al. Physician perceptions of GLP-1 receptor agonists in the UK. Curr Med Res Opin. 2016;1–8. doi:10.1185/03007995.2016.1147025.
25. J.Jendle, G.Grunberger, T.Blevins, et al., Efficacy and safety of dulaglutide in the treatment of type 2 diabetes:a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program. Diabetes Metab Res Rev. 2016. doi:10.1002/dmrr.2810. [Epub ahead of print].
26. C.Wysham, T.Blevins, R.Arakaki, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care. 2014;37:2159–2167. doi:10.2337/dc13-2760.
27. F.Giorgino, M.Benroubi, J.-H.Sun, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care. 2015;38:2241–2249. doi:10.2337/dc14-1625.
28. G.Umpierrez, S.Tofe Povedano, F.Perez Manghi, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37:2168–2176. doi:10.2337/dc13-2759.
29. L.Blonde, J.Jendle, J.Gross, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4):a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385:2057–2066. doi:10.1016/S0140-6736(15)60936-9.
30. M.Nauck, R.S.Weinstock, G.E.Umpierrez, et al. Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care. 2014;37:2149–2158. doi:10.2337/dc13-2761.
31. R.S.Weinstock, B.Guerci, G.Umpierrez, et al. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5):a randomized, phase III study. Diabetes Obes Metab. 2015;17:849–858. doi:10.1111/dom.12479.
32. K.M.Dungan, S.T.Povedano, T.Forst, et al. Once-weekly dulaglutide 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;384:1349–1357. doi:10.1016/S0140-6736(14)60976-4.
33. K.M.Dungan, R.Weitgasser, F.Perez Manghi, et al. A 24-week study to evaluate the efficacy and safety of once weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18:475–482. doi:10.1111/dom.12634.
34. P.Hollander. Anti-diabetes and anti-obesity medications:effects on weight in people with diabetes. Diabetes Spectr. 2007;20:159–165.
35. H.L.Gelhorn, J.L.Poon, E.W.Davies, et al. Evaluating diabetes patients’ preferences for profiles of Glp-1 treatments in the United Kingdom:a discrete choice experiment. Value in Health:the Journal of the International Society for Pharmacoeconomics and Outcomes Research. 2015;18:A614. doi:10.1016/j.jval.2015.09.2133.
36. Trulicity [Instruction for Use]. Indianapolis (IN):Lilly USA, LCC; 2014.
37. G.Matfin, K.Van Brunt, A.G.Zimmermann, et al. Safe and effective use of the once weekly dulaglutide single-dose pen in injection-naive patients with type 2 diabetes. J Diabetes Sci Technol. 2015;9:1071–1079. doi:10.1177/1932296815583059.
38. D.A.Revicki. Patient assessment of treatment satisfaction:methods and practical issues. Gut. 2004;53(Suppl 4):iv40–44.
39. R.Shikiar, E.Flood, R.Siddique, et al. Development and validation of the gastroesophageal reflux disease treatment satisfaction questionnaire. Dig Dis Sci. 2005;50:2025–2033. doi:10.1007/s10620-005-3002-1.
40. J.Speight. Assessing patient satisfaction:concepts, applications, and measurement. Value in Health:the Journal of the International Society for Pharmacoeconomics and Outcomes Research. 2005;8(Suppl 1):S6–8. doi:10.1111/j.1524-4733.2005.00071.x.
41. M.Reaney, M.Yu, M.Lakshmanan, et al. Treatment satisfaction in people with type 2 diabetes mellitus treated with once-weekly dulaglutide:data from the AWARD-1 and AWARD-3 clinical trials. Diabetes Obes Metab. 2015;17:896–903. doi:10.1111/dom.12527.
42. M.Yu, K.van Brunt, O.J.Varnado, et al. Patient-reported outcome results in patients with type 2 diabetes treated with once weekly dulaglutide:data from the AWARD phase 3 clinical trial programme. Diabetes Obes Metab. 2015. doi:10.1111/dom.12624.
43. Trulicity [Summary of Product Characteristics]. Houten (The Netherlands):Eli Lilly and Company; 2014.
44. L.S.Matza, K.D.Stewart, E.W.Davies, et al. Health state utilities associated with attributes of weekly injection devices for treatment of type 2 diabetes. The 18th Annual European ISPOR Congress; 2015 Nov7–11; Milan, Italy; 2015.
45. Z.Skrivanek, B.L.Gaydos, J.Y.Chien, 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.
46. K.C.Ferdinand, W.B.White, D.A.Calhoun, et al. Effects of the once-weekly glucagon-like peptide-1 receptor agonist dulaglutide on ambulatory blood pressure and heart rate in patients with type 2 diabetes mellitus. Hypertension. 2014;64:731–737. doi:10.1161/HYPERTENSIONAHA.114.03062.
47. K.C.Ferdinand, F.T.Botros, C.M.Atisso, et al. Cardiovascular safety for once-weekly dulaglutide in type 2 diabetes:a pre-specified meta-analysis of prospectively adjudicated cardiovascular events. Cardiovasc Diabetol. 2016;15:38. doi:10.1186/s12933-016-0355-z.
48. K.M.Dungan, I.Raz, Z.Skrivanek, et al. Achieving the composite endpoint of glycated haemoglobin <7.0%, no weight gain and no hypoglycaemia in the once-weekly dulaglutide AWARD programme. Diabetes Obes Metab. 2016;18:49–55. doi:10.1111/dom.12575.