The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial

Diabetes Therapy

Volumn 8, Issue 1, 2017, Pages 101-114

  Linjawi, Sultan ^a   Bode, Bruce W ^b   Chaykin, Louis B ^c   Courrèges, Jean Pierre ^d   Handelsman, Yehuda ^e   Lehmann, Lucine M ^f   Mishra, Abhishek ^g   Simpson, Richard W ^h  

^a Coffs Endocrine & Diabetes Services ^*  (Australia)

^b ATLANTA DIABETES ASSOCIATES   (United States)

^c Meridien Research   (United States)

^d General Hospital   (France)

^e Metabolic Institute of America   (United States)

^f NOVO NORDISK A S   (Denmark)

^g Raheja Towers   (India)

^h EASTERN HEALTH   (Australia)

Author keywords

Clinical trial; GLP 1 receptor agonist; IDegLira; Insulin therapy; Type 2 diabetes

Indexed keywords

ANTIDIABETIC AGENT; CHOLESTEROL; EXENDIN 4; FATTY ACID; GLUCOSE; INSULIN DEGLUDEC PLUS LIRAGLUTIDE; LIRAGLUTIDE; METFORMIN; PIOGLITAZONE; SULFONYLUREA; TRIACYLGLYCEROL; VERY LOW DENSITY LIPOPROTEIN CHOLESTEROL;

ABDOMINAL DISCOMFORT; ADULT; ARTICLE; BODY MASS; BODY WEIGHT; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG HYPERSENSITIVITY; FEMALE; FOOT FRACTURE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEOPLASM; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; PATIENT-REPORTED OUTCOME; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; THYROID MEDULLARY CARCINOMA; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION;

EID: 85012159492     PISSN: 18696953     EISSN: 18696961     Source Type: Journal    
DOI: 10.1007/s13300-016-0218-3     Document Type: Article

References (28)

1. Garber AJ, Abrahamson MJ, Barzilay JI, et al. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013;19:327–36.
2. 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;38:140–9.
3. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32:193–203.
4. Eckerle Mize DL, Salehi M. The place of GLP-1-based therapy in diabetes management: differences between DPP-4 inhibitors and GLP-1 receptor agonists. Curr Diabetes Rep. 2013;13:307–18.
5. Buse JB, Bergenstal RM, Glass LC, et al. Use of twice-daily exenatide in basal insulin-treated patients with type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2011;154:103–12.
6. DeVries JH, Bain SC, Rodbard HW, et al. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012;35:1446–54.
7. Mathieu C, Rodbard HW, Cariou B, et al. A comparison of adding liraglutide versus a single daily dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON). Diabetes Obes Metab. 2014;16:636–44.
8. Riddle MC, Forst T, Aronson R, et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1). Diabetes Care. 2013;36:2497–503.
9. Seino Y, Kaneko S, Fukuda S, et al. Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: a 36-week, randomized, double-blind, parallel-group trial. J Diabetes Investig. 2016;7:565–73.
10. Novo Nordisk. Xultophy summary of product characteristics. 2016. https://www.medicines.org.uk/emc/medicine/29493. Accessed 25 Sept 2016.
11. Gough SC, Bode B, Woo V, et al. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol. 2014;2:885–93.
12. Gough SC, Bode BW, Woo VC, et al. One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial. Diabetes Obes Metab. 2015;17:965–73.
13. Buse JB, Vilsboll T, Thurman J, et al. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care. 2014;37:2926–33.
14. Rodbard HW, Bode BW, Harris SB, et al. Safety and efficacy of IDegLira added to sulphonylureas alone or sulphonylureas and metformin in insulin-naïve people with type 2 diabetes: the DUAL IV trial. Diabet Med. 2016. doi:10.1111/dme.13256 (epub ahead of print).
15. Lingvay I, Perez Manghi F, Garcia-Hernandez P, et al. Effect of insulin glargine up-titration vs insulin degludec/liraglutide on glycated hemoglobin levels in patients with uncontrolled type 2 diabetes: the DUAL V trial. JAMA. 2016;315:898–907.
16. International Conference of Harmonisation. ICH harmonised tripartite guideline. Good Clin Pract 1996. http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html. Accessed 16 Sept 2016.
17. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–4.
18. Brod M, Hammer M, Christensen T, et al. Understanding and assessing the impact of treatment in diabetes: the treatment-related impact measures for diabetes and devices (TRIM-diabetes and TRIM-diabetes device). Health Qual Life Outcomes. 2009;7:83.
19. Brod M, Christensen T, Hammer M, et al. Examining the ability to detect change using the TRIM-diabetes and TRIM-diabetes device measures. Qual Life Res. 2011;20:1513–8.
20. Bradley C. The diabetes treatment satisfaction questionnaire: DTSQ. Chur: Harwood Academic; 1994. p. 111–33.
21. Garber AJ. Long-acting glucagon-like peptide 1 receptor agonists: a review of their efficacy and tolerability. Diabetes Care. 2011;34(Suppl 2):S279–84.
22. Holman RR, Thorne KI, Farmer AJ, et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007;357:1716–30.
23. Aroda VR, Bailey TS, Cariou B, et al. Effect of adding insulin degludec to treatment in patients inadequately controlled with metformin and liraglutide: a double-blind, randomized controlled trial. Diabetes Obes Metab. 2016;18:663–70.
24. Philis-Tsimikas A, Del PS, Satman I, et al. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Diabetes Obes Metab. 2013;15:760–6.
25. Rodbard HW, Cariou B, Zinman B, et al. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabet Med. 2013;30:1298–304.
26. Swinnen SG, Dain MP, Mauricio D, et al. Continuation versus discontinuation of insulin secretagogues when initiating insulin in type 2 diabetes. Diabetes Obes Metab. 2010;12:923–5.
27. American Diabetes Association. Standards of medical care in diabetes—2016. Diabetes Care. 2016;39(Suppl. 1):S1–112.
28. Simpson R, King A. Can a fixed-ratio combination of insulin degludec and liraglutide help type 2 diabetes patients to optimize glycemic control across the day? Expert Rev Clin Pharmacol. 2015;8:179–88.