Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial
Abstract
Background Durability of glycaemic control might reduce disease burden and improve long-term outcomes. DUAL VIII investigated the durability of insulin degludec plus liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) in patients with type 2 diabetes with the use of a visit schedule that mirrored routine clinical practice. Methods In this 104-week international, multicentre, open-label, phase 3b randomised controlled trial, insulin-naive patients aged 18 years and older, with HbA 1c between 7·0-11·0% (53-97 mmol/mol), BMI of 20 kg/m 2 or higher, on stable doses of oral antidiabetic drugs, were recruited from outpatient clinics. Patients were randomly assigned 1:1, with a simple sequential allocation randomisation schedule (block size of four), to IDegLira or IGlar U100, each treatment being an add-on to existing therapy. The internal safety committee, the independent external committee, and the personnel involved in defining the analysis sets were masked until the database was released for statistical analysis. Patients and all other investigators were not masked. In the IDegLira group, patients were given degludec 100 units/mL plus liraglutide 3·6 mg/mL in a 3 mL prefilled PDS290 pen for subcutaneous injection; in the IGlar U100 group, patients were given IGlar U100 solution, in a 3 mL prefilled Solostar pen for subcutaneous injection. Both treatments were given once daily at any time of day and it was recommended that the time of day remained the same t…
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Some data support later combination therapy for longer durability of glycemic effect.
“However, some data support initial combination therapy for more rapid attainment of glycemic goals (113,114) and later combination therapy for longer durability of glycemic effect (115).”
From 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025 (2025) · cites this paper as [115]
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Davies, M. J., Aroda, V. R., Collins, B. S., Gabbay, R. A., Green, J., Maruthur, N. M., Rosas, S. E., Del Prato, S., Mathieu, C., Mingrone, G., et al. (2022) · Diabetes Care · doi:10.2337/dci22-0034 · Cited by 2,104 · see citing works
Self-citation9. Pharmacologic Approaches to Glycemic Treatment: <i>Standards of Medical Care in Diabetes—2022</i>
American Diabetes Association Professional Practice Committee (2022) · Diabetes Care · doi:10.2337/dc22-s009 · Cited by 1,555 · see citing works
Davies, M. J., Aroda, V. R., Collins, B. S., Gabbay, R. A., Green, J., Maruthur, N. M., Rosas, S. E., Del Prato, S., Mathieu, C., Mingrone, G., et al. (2022) · Diabetologia · doi:10.1007/s00125-022-05787-2 · Cited by 1,048 · see citing works
Self-citation9. Pharmacologic Approaches to Glycemic Treatment: <i>Standards of Medical Care in Diabetes—2021</i>
American Diabetes Association (2021) · Diabetes Care · doi:10.2337/dc21-s009 · Cited by 972 · see citing works
9. Pharmacologic Approaches to Glycemic Treatment: <i>Standards of Care in Diabetes—2023</i>
ElSayed, N. A., Aleppo, G., Aroda, V. R., Bannuru, R. R., Brown, F. M., Bruemmer, D., Collins, B. S., Hilliard, M. E., Isaacs, D., Johnson, E. L., et al. (2023) · Diabetes Care · doi:10.2337/dc23-s009 · Cited by 851 · see citing works
Self-citation9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Bajaj, M., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Echouffo-Tcheugui, J. B., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s009 · Cited by 728 · see citing works
- Authors
- Aroda, V. R., González-Galvez, G., Grøn, R., Halladin, N., Haluzík, M., Jermendy, G., Kok, A., Őrsy, P., Sabbah, M., Sesti, G., & Silver, R.
- Affiliations
- Brigham and Women's Hospital (US)
- Novo Nordisk (Denmark) (DK)
- Bajcsy-Zsilinszky Kórház és Rendelőintézet (HU)
- Hadassah Medical Center (IL)
- Magna Graecia University (IT)
- Southern New Hampshire Medical Center (US)
- Corresponding author
- Aroda, Vanita R
- Venue
- The Lancet Diabetes & Endocrinology
- Publisher
- Elsevier BV
- Published
- 2019-08
- Volume
- 7
- Issue
- 8
- Pages
- 596-605
- ISSN
- 2213-8587 (ISSN-L)
- OpenAlex
- W2949026862
- Cited by
- 68
- References
- 6
- Citations by year
- 2026: 4 · 2025: 10 · 2024: 9 · 2023: 8 · 2022: 12 · 2021: 7 · 2020: 14 · 2019: 4
- FWCI
- 7.49
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet Diabetes & Endocrinology (publishedVersion)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes, insulin degludec, liraglutide, insulin glargine U100, treatment intensification, HbA1c, insulin-naive patients, oral antidiabetic drugs, GLP-1 receptor agonists, real-world clinical practice
- MeSH terms
- Insulin Glargine, Liraglutide, Aged, Diabetes Mellitus, Type 2, Drug Combinations, Female, Humans, Hypoglycemic Agents, Male, Middle Aged, Treatment Outcome, Insulin, Long-Acting
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