Continuous subcutaneous delivery of exenatide via ITCA 650 leads to sustained glycemic control and weight loss for 48 weeks in metformin-treated subjects with type 2 diabetes

Journal of Diabetes and its Complications

Volumn 28, Issue 3, 2014, Pages 393-398

  Henry, Robert R ^a   Rosenstock, Julio ^b   Logan, Douglas ^c   Alessi, Thomas ^d   Luskey, Kenneth ^d   Baron, Michelle A ^d  

^a VA SAN DIEGO HEALTHCARE SYSTEM   (United States)

^b DALLAS DIABETES AND ENDOCRINE CENTER AT MEDICAL CITY   (United States)

^c Medpace Reference Laboratories   (United States)

^d Research Triangle   (United States)

Author keywords

Exenatide; ITCA 650; Type 2 diabetes

Indexed keywords

DRUG CARRIER; EXENDIN 4; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; ITCA 650; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METFORMIN; TRIACYLGLYCEROL; UNCLASSIFIED DRUG; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; PEPTIDE; VENOM;

ADULT; AGED; AMYLASE BLOOD LEVEL; ARTHRALGIA; ARTICLE; BODY WEIGHT; CALCITONIN BLOOD LEVEL; CONTROLLED STUDY; DIARRHEA; DRUG DELIVERY SYSTEM; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHEMA; FEMALE; FEVER; FOLLOW UP; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INJECTION SITE INFECTION; INJECTION SITE PAIN; INJECTION SITE PRURITUS; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; THYROTROPIN BLOOD LEVEL; TREATMENT DURATION; TREATMENT RESPONSE; TRIACYLGLYCEROL BLOOD LEVEL; URINARY TRACT INFECTION; VOMITING; WEIGHT REDUCTION; BLOOD; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DOSE RESPONSE; DRUG COMBINATION; DRUG EFFECTS; LONGITUDINAL STUDY; METABOLISM; MIDDLE AGED; PATHOPHYSIOLOGY; PHYSIOLOGY; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME;

ADULT; AGED; BLOOD GLUCOSE; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INFUSIONS, SUBCUTANEOUS; LONGITUDINAL STUDIES; MALE; METFORMIN; MIDDLE AGED; PEPTIDES; TREATMENT OUTCOME; VENOMS; WEIGHT LOSS;

EID: 84899575503     PISSN: 10568727     EISSN: 1873460X     Source Type: Journal    
DOI: 10.1016/j.jdiacomp.2013.12.009     Document Type: Article

References (28)

1. A. Astrup, R. Carraro, N. Finer, A. Harper, M. Kunesova, and M.E. Lean et al. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide International Journal of Obesity 36 2012 843 854
2. L. Breitscheidel, S. Stamenitis, F.W. Dippel, and O. Schöffski Economic impact of compliance to treatment with antidiabetes medication in type 2 diabetes mellitus: A review paper Journal of Medical Economics 13 2010 8 15
3. M. Bron, M. Marynchenko, H. Yang, A.P. Yu, and E.Q. Wu Hypoglycemia, treatment discontinuation, and costs in patients with type 2 diabetes mellitus on oral antidiabetic drugs Postgraduate Medicine 124 2012 124 132
4. M. Buysschaert, V. Preumont, and P.R. Oriot et al. UCL Study Group for Exenatide. One-year metabolic outcomes in patients with type 2 diabetes treated with exenatide in routine practice Diabetes & Metabolism 36 2010 381 388
5. S. Casagrande, J.E. Fradkin, S.H. Saydah, K.F. Rust, and C.C. Cowie The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010 Diabetes Care 36 2013 2271 2279
6. B.M. Cheung, K.L. Ong, S.S. Cherny, P.C. Sham, A.W. Tso, and K.S. Lam Diabetes prevalence and therapeutic target achievement in the United States, 1999 to 2006 American Journal of Medicine 122 2009 443 453
7. C.E. Cooke, H.Y. Lee, Y.P. Tong, and S.T. Haines Persistence with injectable antidiabetic agents in members with type 2 diabetes in a commercial managed care organization Current Medical Research and Opinion 26 2010 231 238
8. J.A. Cramer A systematic review of adherence with medications for diabetes Diabetes Care 27 2004 1218 1224
9. M. Diamant, L. Van Gaal, and S. Stranks et al. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks Diabetes Care 35 2012 683 689
10. J.S. Egginton, J.L. Ridgeway, and N.D. Shah et al. Care management for Type 2 diabetes in the United States: A systematic review and meta-analysis BMC Health Services Research 12 2012 72
11. W.K. Fakhoury, C. Lereun, and D. Wright A meta-analysis of placebo-controlled clinical trials assessing the efficacy and safety of incretin-based medications in patients with type 2 diabetes Pharmacology 86 2010 44 57
12. B. Gallwitz, J. Guzman, and F. Dotta et al. Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): An open-label, randomised controlled trial Lancet 379 2012 2270 2278
13. W.C. Ha, S.J. Oh, and J.H. Kim et al. Severe hypoglycemia is a serious complication and becoming an economic burden in diabetes Diabetes and Metabolism Journal 36 2012 280 284
14. R.R. Henry, D. Logan, T. Alessi, and M.A. Baron A randomized, open-label, multicenter, 4-week study to evaluated the tolerability and pharmacokinetics of ITCA 650 in subjects with type 2 diabetes Clinical Therapeutics 35 2013 634 645
15. R.R. Henry, J. Rosenstock, D. Logan, T. Alessi, K. Luskey, and M.A. Baron Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 vs. twice daily exenatide injections in metformin-treated type 2 diabetes Diabetes Care 36 2013 2559 2565
16. P.M. Ho, J.S. Rumsfeld, and F.A. Masoudi et al. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus Archives of Internal Medicine 166 2006 1836 1841
17. A.K. Jha, R.E. Aubert, J. Yao, J.R. Teagarden, and R.S. Epstein Greater adherence to diabetes drugs is linked to less hospital use and could save nearly $5 billion annually Health Affairs (Project Hope) 31 2012 1836 1846
18. C.E. Koro, P. Chhabra, M. Stender, C.V. Spain, J.K. Allen, and H.J. Krzywy Treatment utilization patterns of GLP-1 agonists and DPP-4 inhibitors among type 2 diabeteics in a UlS. Commercially insured population: 2005-2011 Abstract #1589-P presented at the American Diabetes Association Annual Meeting 2013, June (Chicago, Illinois)
19. L. Macconell, R. Pencek, Y. Li, D. Maggs, and L. Porter Exenatide once weekly: Sustained improvement in glycemic control and cardiometabolic measures through 3 years Diabetes, Metabolic Syndrome and Obesity 6 2013 31 41
20. D.P. Nau Recommendations for improving adherence to type 2 diabetes mellitus therapy - focus on optimizing oral and non-insulin therapies The American Journal of Managed Care 18 3 Suppl 2012 S49 S54
21. B.J. Quilliam, J.C. Simeone, A.B. Ozbay, and S.J. Kogut The incidence and costs of hypoglycemia in type 2 diabetes The American Journal of Managed Care 17 2011 673 680
22. E. Raum, H.U. Krämer, and G. Rüter et al. Medication non-adherence and poor glycaemic control in patients with type 2 diabetes mellitus Diabetes Research and Clinical Practice 97 2012 377 384
23. C.M. Rohloff, T.R. Alessi, B. Yang, J. Dahms, J.P. Carr, and S.D. Lautenbach DUROS technology delivers peptides and proteins at consistent rate continuously for 3 to 12 months Journal of Diabetes Science and Technology 2 2008 461 467
24. M. Salas, D. Hughes, A. Zuluaga, K. Vardeva, and M. Lebmeier Costs of medication nonadherence in patients with diabetes mellitus: A systematic review and critical analysis of the literature Value in Health 12 2009 915 922
25. D.S. Shyangdan, P.L. Royle, C. Clar, P. Sharma, and N.R. Waugh Glucagon-like peptide analogues for type 2 diabetes mellitus: Systematic review and meta-analysis BMC Endocrine Disorders 10 2010 20
26. S.A. Williams, L. Shi, S.K. Brenneman, J.C. Johnson, J.C. Wegner, and V. Fonseca The burden of hypoglycemia on healthcare utilization, costs, and quality of life among type 2 diabetes mellitus patients Journal of Diabetes and its Complications 26 2012 399 406
27. W.D. Willis, J.I. Diago-Cabezudo, A. Madec-Hily, and A. Aslam Medical resource use, disturbance of daily life and burden of hypoglycemia in insulin-treated patients with diabetes: Results from a European online survey Expert Review of Pharmacoeconomics & Outcomes Research 13 2013 123 130
28. B. Yang, C. Negulescu, and R. D'vaz et al. Stability of ITCA 650 for continuous subcutaneous delivery of exenatide at body temperature for 12 months Abstract No. A189 presented at the Ninth Annual Diabetes Technology Meeting, San Francisco, CA 2009