7,089
Views
22
CrossRef citations to date
0
Altmetric
Diabetes

An indirect treatment comparison of the efficacy of insulin degludec/liraglutide (IDegLira) and insulin glargine/lixisenatide (iGlarLixi) in patients with type 2 diabetes uncontrolled on basal insulin

, , , , , & show all
Pages 340-347 | Received 26 Sep 2017, Accepted 20 Nov 2017, Published online: 03 Dec 2017

References

  • 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
  • Holst JJ, Vilsbøll T. Combining GLP-1 receptor agonists with insulin: therapeutic rationales and clinical findings. Diabetes Obes Metab 2013;15:3-14
  • Holman RR. Assessing the potential for alpha-glucosidase inhibitors in prediabetic states. Diabetes Res Clin Pract 1998;40(Suppl):S21-S25
  • Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of type I and type II diabetes. Diabetologia 2002;45:937-48
  • Flint A, Kapitza C, Hindsberger C, et al. The once-daily human glucagon-like peptide-1 (GLP-1) analog liraglutide improves postprandial glucose levels in type 2 diabetes patients. Adv Ther 2011;28:213-26
  • Balena R, Hensley IE, Miller S, et al. Combination therapy with GLP-1 receptor agonists and basal insulin: a systematic review of the literature. Diabetes Obes Metab 2013;15:485-502
  • Flint A, Kapitza C, Zdravkovic M. The once-daily human GLP-1 analogue liraglutide impacts appetite and energy intake in patients with type 2 diabetes after short-term treatment. Diabetes Obes Metab 2013;15:958-62
  • 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
  • Buse JB, Vilsbøll 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
  • 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
  • Rosenstock J, Aronson R, Grunberger G, et al. Benefits of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide, versus insulin glargine and lixisenatide monocomponents in type 2 diabetes inadequately controlled on oral agents: The LixiLan-O Randomized Trial. Diabetes Care 2016;39:2026-35
  • Lingvay I, Pérez Manghi F, García-Hernández 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 randomized clinical trial. JAMA 2016;315:898-907
  • Aroda VR, Rosenstock J, Wysham C, et al. Efficacy and safety of lixilan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L Randomized Trial. Diabetes Care 2016;39:1972-80
  • Peyrot M, Rubin RR, Kruger DF, et al. Correlates of insulin injection omission. Diabetes Care 2010;33:240-5
  • Peyrot M, Barnett AH, Meneghini LF, et al. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabetic Med 2012;29:682-9
  • Aroda VR, Jaeckel E, Jarlov H, et al. Incidence of gastrointestinal side effects similar between IDegLira and non-GLP-1RA comparators. Poster session presented at: 75th Scientific Session of the American Diabetes Association (ADA); June 5–9, 2015; Boston, MA. Poster 1009-P.
  • IDegLira Summary of Product Characteristics. Bagsvaerd, Denmark: European Medicines Agency 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002647/WC500177657.pdf
  • iGlarLixi Summary of Product Characteristics. Paris, France: European Medicines Agency 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004243/WC500224673.pdf
  • Maiorino MI, Chiodini P, Bellastella G, et al. Insulin and glucagon-like peptide 1 receptor agonist combination therapy in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Care 2017;40:614-24
  • Insulin degludec/liraglutide (IDegLira) treatment to improve glycemic control in adults with type 2 diabetes mellitus NDA 208583 Briefing Document. Silver Spring, MD: U.S. Food and Drug Administration 2016. https://wayback.archive-it.org/7993/20170405215035/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM502076.pdf
  • Lixisenatide and insulin glargine/lixisenatide Briefing Document. Silver Spring, MD: U.S. Food and Drug Administration 2016. https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm502559.pdf
  • Wysham C, Bonadonna RC, Aroda V, et al. Efficacy and safety of LixiLan (iGlarLixi), an insulin glargine/lixisenatide titratable fixed-ratio combination vs insulin glargine according to baseline characteristics in patients with type 2 diabetes from the LixiLan-L Trial. Poster session presented at the 76th Scientific Session of the American Diabetes Association (ADA); June 10–14, 2016. New Orleans, LA. Poster no. 1018-P
  • Jansen JP, Trikalinos T, Cappelleri JC, et al. Indirect treatment comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision making: an ISPOR-AMCP-NPC Good Practice Task Force report. Value Health 2014;17:157-73
  • US FDA. Silver Spring, MD: Drug and device manufacturer communications with payors, formulary committees, and similar entities – Questions and Answers 2017. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537347.pdf
  • Wysham C, Bhargava A, Chaykin L, et al. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: the SWITCH 2 randomized clinical trial. JAMA 2017;318:45-56
  • Wysham C, Gumprecht J, Lane L, et al. Insulin degludec (IDeg) shows consistent risk reductions across hypoglycemia definitions versus insulin glargine U100 (IGlar) in the SWITCH 1 and 2 trials. Poster session presented at: 77th Scientific Sessions of the American Diabetes Association (ADA); June 9–13, 2017; San Diego, CA. Poster 974-P
  • Bucher HC, Guyatt GH, Griffith LE, et al. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 1997;50:683-91
  • Spiegelhalter D, Thomas A, Best N, et al. WinBUGS user manual version 1.4. Cambridge, UK: MRC Biostatistics Unit; January 2003
  • Lunn D, Spiegelhalter D, Thomas A, et al. The BUGS project: evolution, critique and future directions. Stat Med 2009;28:3049-67
  • Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321:405-12
  • Williamson DF, Thompson TJ, Thun M, et al. Intentional weight loss and mortality among overweight individuals with diabetes. Diabetes Care 2000;23:1499-504
  • Hayes AJ, Leal J, Gray AM, et al. UKPDS outcomes model 2: a new version of a model to simulate lifetime health outcomes of patients with type 2 diabetes mellitus using data from the 30 year United Kingdom Prospective Diabetes Study: UKPDS 82. Diabetologia 2013;56:1925-33
  • Baxter M, Hudson R, Mahon J, et al. Estimating the impact of better management of glycaemic control in adults with Type 1 and Type 2 diabetes on the number of clinical complications and the associated financial benefit. Diabet Med 2016;33:1575-81
  • Huetson P, Palmer JL, Levorsen A, et al. Cost-effectiveness of once daily GLP-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway. J Med Econ 2015;18:573-85
  • Ericsson Å, Lundqvist A. Cost Effectiveness of insulin degludec plus liraglutide (IDegLira) in a fixed combination for uncontrolled type 2 diabetes mellitus in Sweden. Appl Health Econ Health Policy 2017;15:237-48
  • Heise T, Hermanski L, Nosek L, et al. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab 2012;14:859-64
  • Ratner RE, Gough SC, Mathieu C, et al. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab 2013;15:175-84
  • Vora J, Christensen T, Rana A, et al. Insulin degludec versus insulin glargine in type 1 and type 2 diabetes mellitus: a meta-analysis of endpoints in phase 3a trials. Diabetes Ther 2014;5:435-46
  • Wysham C, Bhargava A, Chaykin L, et al. SWITCH 2: reduced hypoglycemia with insulin degludec (IDeg) vs. insulin glargine (IGlar), both U100, in patients with T2D at high risk of hypoglycemia: a randomized, double-blind, crossover trial. Poster presented at the 76th Scientific Session of the American Diabetes Association (ADA); June 10–14, 2016. New Orleans, LA. Poster no. 90-LB
  • Garber AJ, King AB, Del Prato S, et al. Insulin degludec, an ultra-long-acting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012;379:1498-507
  • Meneghini L, Atkin SL, Gough SC, et al. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care 2013;36:858-64
  • Schmider W, Belder R, Lee M, et al. Impact of dose capping in insulin glargine/lixisenatide fixed-ratio combination trials in patients with T2D. Poster session presented at the 77th Scientific Sessions of the American Diabetes Association (ADA); June 9–13, 2017. San Diego, CA. Poster 1101-P
  • International Hypoglycaemia Study Group. Glucose concentrations of less than 3.0 mmol/L (54 mg/dL) should be reported in clinical trials: a joint position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2017;40:155-7

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.