Study S000357

Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

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

Registration

Registration: NCT01541215
Acronym: Ellipse™
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 135
Start: 2012-11-13
Primary completion: 2017-11-15
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:liraglutide; DRUG:placebo; DRUG:metformin
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2011-002605-29; OTHER:P/288/2010; OTHER:U1111-1121-8743; REGISTRY:CTRI/2013/10/004082

Registered primary outcomes

Change in HbA1c (Glycosylated Haemoglobin) [Week 0, week 26]

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
R0023542	Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial. Bensignor MO, Pediatric obesity	2021	Randomized trial	PMID 33634589 DOI	cites ClinicalTrials.gov:NCT01541215; registry reference DERIVED:33634589
R0024737	Liraglutide in Children and Adolescents with Type 2 Diabetes. Tamborlane WV, The New England journal of medicine	2019	Randomized trial	PMID 31034184 DOI	cites ClinicalTrials.gov:NCT01541215; registry reference BACKGROUND:31034184
R0051939	Expanding Treatment Options for Youth With Type 2 Diabetes: Current Problems and Proposed Solutions William V. Tamborlane, Diabetes Care	2016	Other	PMID 26908928 DOI	cites ClinicalTrials.gov:NCT01541215