Efficacy and safety of ITCA 650, a novel drug-Device GLP-1 receptor agonist, in type 2 diabetes uncontrolled with oral antidiabetes drugs: The FREEDOM-1 trial

Diabetes Care

Volumn 41, Issue 2, 2018, Pages 333-340

  Rosenstock, Julio ^a   Buse, John B ^b   Azeem, Rehan ^c   Prabhakar, Prakash ^c   Kjems, Lise ^c   Huang, Holly ^c   Baron, Michelle A ^c  

^a Dallas Diabetes and Endocrine Center at Medical City   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^c Research Triangle   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMYLASE; EXENDIN 4; GLITAZONE DERIVATIVE; HEMOGLOBIN A1C; METFORMIN; PLACEBO; SULFONYLUREA DERIVATIVE; TRIACYLGLYCEROL LIPASE; ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE 1 RECEPTOR; GLYCOSYLATED HEMOGLOBIN; PEPTIDE; VENOM;

ADULT; AGED; AMYLASE BLOOD LEVEL; BLOOD SAMPLING; BODY WEIGHT; CHOLELITHIASIS; CLINICAL EFFECTIVENESS; CONFERENCE PAPER; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; EQUIPMENT DESIGN; FEMALE; HUMAN; HYPOGLYCEMIA; INJECTION SITE BLEEDING; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN BRUISING; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; VERY ELDERLY; VOMITING; AGONISTS; CLINICAL TRIAL; DEVICES; DRUG DELIVERY SYSTEM; DRUG EFFECT; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PROCEDURES; YOUNG ADULT;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG DELIVERY SYSTEMS; FEMALE; GLUCAGON-LIKE PEPTIDE-1 RECEPTOR; GLYCATED HEMOGLOBIN A; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; PEPTIDES; PLACEBOS; SULFONYLUREA COMPOUNDS; TREATMENT OUTCOME; VENOMS; YOUNG ADULT;

EID: 85041229379     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc17-1306     Document Type: Conference Paper

References (25)

1. Breitscheidel L, Stamenitis S, Dippel FW, Schöffski O. Economic impact of compliance to treatment with antidiabetes medication in type 2 diabetes mellitus: a review paper. J Med Econ 2010;13:8–15
2. Egede LE, Gebregziabher M, Dismuke CE, et al. Medication nonadherence in diabetes: longitudinal effects on costs and potential cost savings from improvement. Diabetes Care 2012;35:2533–2539
3. StarkCasagrande 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; 36:2271–2279
4. Nauck M. Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors. Diabetes Obes Metab 2016;18:203–216
5. Palmer SC, Mavridis D, Nicolucci A, et al. Comparison of clinical outcomes and adverse events associated with glucose-lowering drugs in patients with type 2 diabetes: a meta-analysis. JAMA 2016;316:313–324
6. Kjems LL, Holst JJ, Vølund A, Madsbad S. The influence of GLP-1 on glucose-stimulated insulin secretion: effects on beta-cell sensitivity in type 2 and nondiabetic subjects. Diabetes 2003;52:380–386
7. Alatorre C, Fernández Landó L, Yu M, et al. Treatment patterns in patients with type 2 diabetes mellitus treated with GLP-1 receptor agonists: higher adherence and persistence with dulaglutide compared to exenatide QW and liraglutide. Diabetes Obes Metab 2017;19:953–961
8. Yu M, Xie J, Fernandez Lando L, Kabul S, Swindle RW. Liraglutide versus exenatide once weekly: persistence, adherence, and early discontinuation. Clin Ther 2016;38:149–160
9. Wilke T, Mueller S, Groth A, et al. Non-persistence and non-adherence of patients with type 2 diabetes mellitus in therapy with GLP-1 receptor agonists: a retrospective analysis. Diabetes Ther 2016;7:105–124
10. Rohloff CM, Alessi TR, Yang B, Dahms J, Carr JP, Lautenbach SD. DUROS technology delivers peptides and proteins at consistent rate continuously for 3 to 12 months. J Diabetes Sci Technol 2008;2:461–467
11. Yang B, Negulescu C, D’vaz R. 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, 5–7 November 2009, San Francisco, California
12. Henry RR, Logan D, Alessi T, Baron MA. A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmaco-kinetics of ITCA 650 in patients with type 2 diabetes. Clin Ther 2013;35:634–645.e1
13. Henry RR, Rosenstock J, Logan DK, Alessi TR, Luskey K, Baron MA. Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes [published correction appears in Diabetes Care 2013;36: 2559–2565]. Diabetes Care 2013;36:2559–2565
14. Henry RR, Rosenstock J, Logan D, Alessi T, Luskey K, Baron MA. 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. J Diabetes Complications 2014;28:393–398
15. Kayaniyil S, Lozano-Ortega G, Bennett HA, et al. A network meta-analysis comparing exenatide once weekly with other GLP-1 receptor agonists for the treatment of type 2 diabetes mellitus. Diabetes Ther 2016;7:27–43
16. Kim D, MacConell L, Zhuang D, et al. Effects of once-weekly dosing of a long-acting release formulation of exenatide on glucose control and body weight in subjects with type 2 diabetes. Diabetes Care 2007;30:1487–1493
17. Bettge K, Kahle M, Abd El Aziz MS, Meier JJ, Nauck MA. Occurrence of nausea, vomiting and diarrhoea reported as adverse events in clinical trials studying glucagon-like peptide-1 receptor agonists: a systematic analysis of published clinical trials. Diabetes Obes Metab 2017;19:336–347
18. Htike ZZ, Zaccardi F, Papamargaritis D, Webb DR, Khunti K, Davies MJ. Efficacy and safety of glucagon-like peptide-1 receptor agonists in type 2 diabetes: a systematic review and mixed-treatment comparison analysis. Diabetes Obes Metab 2017;19:524–536
19. Calvert MJ, McManus RJ, Freemantle N. Management of type 2 diabetes with multiple oral hypoglycaemic agents or insulin in primary care: retrospective cohort study. Br J Gen Pract 2007; 57:455–460
20. Khunti K, Wolden ML, Thorsted BL, Andersen M, Davies MJ. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care 2013;36: 3411–3417
21. Inzucchi SE, Bergenstal RM, Buse JB, 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
22. Abdul-Ghani MA,Puckett C,Triplitt C,etal.Ini-tial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT): a randomized trial. Diabetes Obes Metab 2015;17:268–275
23. Rosenstock J, Hansen L, Zee P, et al. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care 2015; 38:376–383
24. Thomsen RW, Baggesen LM, Søgaard M, et al. Early glycaemic control in metformin users receiving their first add-on therapy: a population-based study of 4,734 people with type 2 diabetes. Dia-betologia 2015;58:2247–2253
25. Henry RR, Klein EJ, Han J, Iqbal N. Efficacy and tolerability of exenatide once weekly over 6 years in patients with type 2 diabetes: an uncontrolled open-label extension of the DURATION-1 study. Diabetes Technol Ther 2016;18:677–686