Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naïve people with Type 2 diabetes: the DUAL IV trial

Diabetic Medicine

Volumn 34, Issue 2, 2017, Pages 189-196

  Rodbard, H W ^a   Bode, B W ^b   Harris, S B ^c   Rose, L ^d   Lehmann, L ^e   Jarlov, H ^e   Thurman, J ^f  

^a Endocrine and Metabolic Consultants   (United States)

^b ATLANTA DIABETES ASSOCIATES   (United States)

^c Ctr for Studies in Family Medicine   (Canada)

^d Diabetes Research Center   (Germany)

^e NOVO NORDISK A S   (Denmark)

^f SSM Rehabilitation Institute   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCITONIN; GLIBENCLAMIDE; GLICLAZIDE; GLIMEPIRIDE; GLIPIZIDE; GLUCOSE; HEMOGLOBIN A1C; INSULIN DEGLUDEC PLUS LIRAGLUTIDE; METFORMIN; PLACEBO; SULFONYLUREA; TRIACYLGLYCEROL LIPASE; ANTIDIABETIC AGENT; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; LIRAGLUTIDE; LONG ACTING INSULIN; SULFONYLUREA DERIVATIVE;

ADD ON THERAPY; ADULT; ARTICLE; CEREBROVASCULAR ACCIDENT; DIABETIC PATIENT; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEADACHE; HEART INFARCTION; HUMAN; HYPOGLYCEMIA; INFLUENZA; MAJOR CLINICAL STUDY; MALE; NAUSEA AND VOMITING; NEUROLOGIC DISEASE; NON INSULIN DEPENDENT DIABETES MELLITUS; RHINOPHARYNGITIS; SIDE EFFECT; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; WEIGHT CHANGE; AGED; CHEMICALLY INDUCED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; CONTROLLED STUDY; DRUG COMBINATION; METABOLISM; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL;

AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; GLYCATED HEMOGLOBIN A; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN, LONG-ACTING; LIRAGLUTIDE; MALE; METFORMIN; MIDDLE AGED; SULFONYLUREA COMPOUNDS;

EID: 84995543386     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/dme.13256     Document Type: Article

References (23)

1. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M et al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2012; 55: 1577–1596.
2. Holman RR. Assessing the potential for alpha-glucosidase inhibitors in prediabetic states. Diabetes Res Clin Pract 1998; 40(Suppl.): S21–S25.
3. Rodbard HW, Jellinger PS, Davidson JA, Einhorn D, Garber AJ, Grunberger G et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type 2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract 2009; 15: 540–559.
4. Turner LW, Nartey D, Stafford RS, Singh S, Alexander GC. Ambulatory treatment of type 2 diabetes in the U.S., 1997-2012. Diabetes Care 2015; 37: 985–992.
5. Spollett GR. Insulin initiation in type 2 diabetes: what are the treatment regimen options and how can we best help patients feel empowered? J Am Acad Nurse Pract 2012; 24(Suppl. 1): 249–259.
6. Swinnen SG, Dain MP, Mauricio D, DeVries JH, Hoekstra JB, Holleman F. Continuation versus discontinuation of insulin secretagogues when initiating insulin in type 2 diabetes. Diabetes Obes Metab 2010; 12: 923–925.
7. Doyle ME, Egan JM. Mechanisms of action of glucagon-like peptide 1 in the pancreas. Pharmacol Ther 2007; 113: 546–593.
8. Flint A, Raben A, Astrup A, Holst JJ. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest 1998; 101: 515–520.
9. Meeran K, O'Shea D, Edwards CM, Turton MD, Heath MM, Gunn I et al. Repeated intracerebroventricular administration of glucagon-like peptide-1-(7-36) amide or exendin-(9-39) alters body weight in the rat. Endocrinology 1999; 140: 244–50.
10. Marre M, Shaw J, Brändle M, Bebakar WM, Kamaruddin NA, Strand J et al. Liraglutide, 1a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycemic and weight control compared with adding rosiglitazone or placebo in subjects with type 2 diabetes (LEAD-1 SU). Diabet Med 2009; 26: 268–278.
11. Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care 2009; 32: 84–90.
12. 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; 20: 2228–2234.
13. DeVries JH, Bain SC, Rodbard HW, Seufert J, D'Alessio D, Thomsen AB et al. on behalf of the Liraglutide-Detemir Study Group. Treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care 2012; 35: 1446–1454.
14. Mathieu C, Rodbard HW, Cariou B, Handelsman Y, Philis-Tsimikas A, Francisco AM et al. BEGIN: VICTOZA ADD-ON (NN1250-3948) study group. A comparison of adding liraglutide versus a single dose of insulin aspart to insulin degludec in subjects with type 2 diabetes (BEGIN: VICTOZA ADD-ON). Diabetes Obes Metab 2014; 16: 636–644.
15. Gough SC, Bode B, Woo V, Rodbard HW, Linjawi S, Poulsen P 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: 885–983.
16. Buse JB, Vilsbøll T, Thurman J, Blevins TC, Langbakke IH, Bøttcher SG et al. Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care 2014; 37: 2926–2933.
17. Gough SC, Bode BW, Woo VC, Rodbard HW, Linjawi S, Zacho M 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: 965–973.
18. World Medical Association. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects. Last amended by the 59th WMA Assembly. Seoul. October 2008.
19. International Conference on Harmonisation.ICH Harmonised Tripartite Guideline. Good Clinical Practice. 01 May 1996.
20. Onishi Y, Iwamoto Y, Yoo SJ, Clauso P, Tamer SC, Park S. Insulin degludec compared with insulin glargine in insulin-naïve patients with type 2 diabetes: A 26-week, randomized, controlled, Pan-Asian, treat-to-target trial. J Diabetes Investig 2013; 4: 605–612.
21. Philis-Tsimikas A, Del Prato S, Satman I, Bhargava A, Dharmalingam M, Skjøth TV et al. Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Diabetes Obes Metab 2013; 15: 760–766.
22. Riddle MC, Rosenstock J, Gerich J and on behalf of the Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003; 26: 3080–3086
23. Novo Nordisk. Xultophy Summary of Product Characteristics. 2014. Available at https://www.medicines.org.uk/emc/medicine/29493.