drugset / Trial / NCT01959529
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.
Timeline
- Start
- 2013-10-29
- Primary completion
- 2016-10-16
- Completion
- 2016-10-16
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (non-inferiority test); Insulin Degludec vs Insulin Glargine; p <0.001; Hazard Ratio (HR) 0.908 (95% CI 0.781 to 1.055) NCT01959529 ↗
paper CONCLUSIONS: Among patients with type 2 diabetes at high risk for cardiovascular events, degludec was noninferior to glargine PMID 28605603 ↗
Publications
- Background Pollock RF, Heller S, Pieber TR, Woo V, Gundgaard J, Hallen N, Luckevich M, Tutkunkardas D, Zinman B; DEVOTE Study Group. Short-term cost-utility of degludec versus glargine U100 for patients with type 2 diabetes at high risk of hypoglycaemia and cardiovascular events: A Canadian setting (DEVOTE 9). Diabetes Obes Metab. 2019 Jul;21(7):1706-1714. doi: 10.1111/dom.13730. Epub 2019 Apr 14.
- Background Pollock RF, Valentine WJ, Marso SP, Andersen A, Gundgaard J, Hallen N, Tutkunkardas D, Magnuson EA, Buse JB; DEVOTE study group. Long-term Cost-effectiveness of Insulin Degludec Versus Insulin Glargine U100 in the UK: Evidence from the Basal-bolus Subgroup of the DEVOTE Trial (DEVOTE 16). Appl Health Econ Health Policy. 2019 Oct;17(5):615-627. doi: 10.1007/s40258-019-00494-3.
- Results Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Frandsen KB, Rabol R, Buse JB. Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) - DEVOTE 1. Am Heart J. 2016 Sep;179:175-83. doi: 10.1016/j.ahj.2016.06.004. Epub 2016 Jun 18.
- Results Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Brown-Frandsen K, Moses A, Skibsted S, Kvist K, Buse JB; DEVOTE Study Group. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med. 2017 Aug 24;377(8):723-732. doi: 10.1056/NEJMoa1615692. Epub 2017 Jun 12.
- Results Zinman B, Marso SP, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Lange M, Brown-Frandsen K, Moses A, Ocampo Francisco AM, Barner Lekdorf J, Kvist K, Buse JB; DEVOTE Study Group. Day-to-day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2). Diabetologia. 2018 Jan;61(1):48-57. doi: 10.1007/s00125-017-4423-z. Epub 2017 Sep 15.
- Results Pieber TR, Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pratley RE, Woo V, Heller S, Lange M, Brown-Frandsen K, Moses A, Barner Lekdorf J, Lehmann L, Kvist K, Buse JB; DEVOTE Study Group. DEVOTE 3: temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality. Diabetologia. 2018 Jan;61(1):58-65. doi: 10.1007/s00125-017-4422-0. Epub 2017 Sep 15.
- Results Pollock RF, Valentine WJ, Marso SP, Gundgaard J, Hallen N, Hansen LL, Tutkunkardas D, Buse JB; DEVOTE Study Group. DEVOTE 5: Evaluating the Short-Term Cost-Utility of Insulin Degludec Versus Insulin Glargine U100 in Basal-Bolus Regimens for Type 2 Diabetes in the UK. Diabetes Ther. 2018 Jun;9(3):1217-1232. doi: 10.1007/s13300-018-0430-4. Epub 2018 Apr 30.
- Results Theilgaard H, Mollerup I, Helmark IC, Endahl L, Hoskin S, Hvelplund A, Amby LK, Moses AC. Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events). Ther Innov Regul Sci. 2019 Mar;53(2):279-286. doi: 10.1177/2168479018776943. Epub 2018 May 24.
- Results Brown-Frandsen K, Emerson SS, McGuire DK, Pieber TR, Poulter NR, Pratley RE, Zinman B, Ranthe MF, Gron R, Lange M, Moses AC, Orsy P, Buse JB; DEVOTE Study Group. Lower rates of cardiovascular events and mortality associated with liraglutide use in patients treated with basal insulin: A DEVOTE subanalysis (DEVOTE 10). Diabetes Obes Metab. 2019 Jun;21(6):1437-1444. doi: 10.1111/dom.13677. Epub 2019 Apr 1.
- Results Pratley RE, Emerson SS, Franek E, Gilbert MP, Marso SP, McGuire DK, Pieber TR, Zinman B, Hansen CT, Hansen MV, Mark T, Moses AC, Buse JB; DEVOTE Study Group. Cardiovascular safety and lower severe hypoglycaemia of insulin degludec versus insulin glargine U100 in patients with type 2 diabetes aged 65 years or older: Results from DEVOTE (DEVOTE 7). Diabetes Obes Metab. 2019 Jul;21(7):1625-1633. doi: 10.1111/dom.13699. Epub 2019 Apr 15.
- Bergenstal RM, Hachmann-Nielsen E, Kvist K, Peters AL, Tarp JM, Buse JB. Increased Derived Time in Range Is Associated with Reduced Risk of Major Adverse Cardiovascular Events, Severe Hypoglycemia, and Microvascular Events in Type 2 Diabetes: A Post Hoc Analysis of DEVOTE. Diabetes Technol Ther. 2023 Jun;25(6):378-383. doi: 10.1089/dia.2022.0447. Epub 2023 May 8.
- Klein KR, Franek E, Marso S, Pieber TR, Pratley RE, Gowda A, Kvist K, Buse JB. Hemoglobin glycation index, calculated from a single fasting glucose value, as a prediction tool for severe hypoglycemia and major adverse cardiovascular events in DEVOTE. BMJ Open Diabetes Res Care. 2021 Nov;9(2):e002339. doi: 10.1136/bmjdrc-2021-002339.
- Amod A, Buse JB, McGuire DK, Pieber TR, Pop-Busui R, Pratley RE, Zinman B, Hansen MB, Jia T, Mark T, Poulter NR; DEVOTE Study Group. Risk factors for kidney disorders in patients with type 2 diabetes at high cardiovascular risk: An exploratory analysis (DEVOTE 12). Diab Vasc Dis Res. 2020 Nov-Dec;17(6):1479164120970933. doi: 10.1177/1479164120970933.
- Heller S, Lingvay I, Marso SP, Philis-Tsimikas A, Pieber TR, Poulter NR, Pratley RE, Hachmann-Nielsen E, Kvist K, Lange M, Moses AC, Andresen MT, Buse JB; DEVOTE Study Group. Risk of severe hypoglycaemia and its impact in type 2 diabetes in DEVOTE. Diabetes Obes Metab. 2020 Dec;22(12):2241-2247. doi: 10.1111/dom.14049. Epub 2020 Jul 9.
- Pratley RE, Husain M, Lingvay I, Pieber TR, Mark T, Saevereid HA, Moller DV, Zinman B; DEVOTE Study Group. Heart failure with insulin degludec versus glargine U100 in patients with type 2 diabetes at high risk of cardiovascular disease: DEVOTE 14. Cardiovasc Diabetol. 2019 Nov 15;18(1):156. doi: 10.1186/s12933-019-0960-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin degludec | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |