Study S001131

A Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02501161
Acronym: DUAL™ VIII
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 1012
Start: 2016-01-31
Primary completion: 2018-10-03
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:insulin degludec/liraglutide; DRUG:insulin glargine
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2014-005639-15; OTHER:U1111-1165-3914; NIH:2014

Registered primary outcomes

Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification [Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0012514	Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes. Philis-Tsimikas A, Journal of diabetes science and technology	2024	Other trial	PMID 36710452 DOI	cites ClinicalTrials.gov:NCT02501161; registry reference DERIVED:36710452
R0012674	A greater proportion of participants with type 2 diabetes achieve treatment targets with insulin degludec/liraglutide versus insulin glargine 100 units/mL at 26 weeks: DUAL VIII, a randomized trial designed to resemble clinical practice. Sesti G, Diabetes, obesity & metabolism	2020	Randomized trial	PMID 31903724 DOI	cites ClinicalTrials.gov:NCT02501161
R0020820	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. Aroda VR, The lancet. Diabetes & endocrinology	2019	Randomized trial	PMID 31189519 DOI	cites ClinicalTrials.gov:NCT02501161; registry reference RESULT:31189519