Study S002341

The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT01836523
Acronym: ADJUNCT ONE™
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 1398
Start: 2013-11
Primary completion: 2015-06
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 1
Interventions: DRUG:liraglutide; DRUG:placebo
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2012-003580-21; OTHER:U1111-1133-0590

Registered primary outcomes

Change From Baseline in HbA1c (Glycosylated Haemoglobin) [Week 0, week 52]
Change From Baseline in Body Weight [Week 0, week 52]
Change From Baseline in Total Daily Insulin Dose [Week 0, week 52]

Linked records (4)

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
R0019604	Determinants of Liraglutide Treatment Discontinuation in Type 1 Diabetes: A Post Hoc Analysis of ADJUNCT ONE and ADJUNCT TWO Randomized Placebo-Controlled Clinical Studies. Shah VN, Journal of diabetes science and technology	2025	Randomized trial	PMID 39717993 DOI	cites ClinicalTrials.gov:NCT01836523; registry reference DERIVED:39717993
R0008931	Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials. Dejgaard TF, Diabetes, obesity & metabolism	2021	Randomized trial	PMID 34463425 DOI	cites ClinicalTrials.gov:NCT01836523; registry reference DERIVED:34463425
R0046904	675-P: Effects of Liraglutide in T1D by Baseline Anthropometrics in ADJUNCT One and Two Thomas Fremming Dejgaard, Diabetes	2021	Randomized trial	DOI	cites ClinicalTrials.gov:NCT01836523
R0025363	Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial. Mathieu C, Diabetes care	2016	Randomized trial	PMID 27506222 DOI	cites ClinicalTrials.gov:NCT01836523; registry reference RESULT:27506222