Study S000508

Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy and Treated in a Primary Care Setting

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

Registration

Registration: NCT02730377
Acronym: LIRA-PRIME
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 1991
Start: 2016-03-28
Primary completion: 2019-08-05
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:liraglutide; DRUG:alpha-glucosidase inhibitors; DRUG:DPP-4 inhibitors; DRUG:meglitinides; DRUG:SGLT-2 inhibitors; DRUG:sulphonylurea; DRUG:thiazolidinediones
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2015-002417-29; OTHER:U1111-1170-7035; NIH:2015

Registered primary outcomes

Time to Inadequate Glycaemic Control [Weeks 26-104]

Linked records (5)

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
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT02730377; registry reference DERIVED:39963952
R0022482	Maintenance of glycaemic control with liraglutide versus oral antidiabetic drugs as add-on therapies in patients with type 2 diabetes uncontrolled with metformin alone: A randomized clinical trial in primary care (LIRA-PRIME). Unger J, Diabetes, obesity & metabolism	2022	Randomized trial	PMID 34622567 DOI	cites ClinicalTrials.gov:NCT02730377
R0049463	922-P: LIRA-PRIME: A Randomized Trial in Primary Care Settings of Liraglutide vs. OAD for Glycemic Control in Patients with Type 2 Diabetes Not in Control on Metformin Jeff Unger, Diabetes	2020	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02730377
R0020891	Trial design and baseline data for LIRA-PRIME: A randomized trial investigating the efficacy of liraglutide in controlling glycaemia in type 2 diabetes in a primary care setting. Unger J, Diabetes, obesity & metabolism	2019	Protocol	PMID 30828917 DOI	registry reference BACKGROUND:30828917
R0052736	LIRA-PRIME Trial Design and Baseline Data—Efficacy in Controlling Glycemia with Liraglutide in a Primary Care Setting Jeff Unger, Diabetes	2018	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02730377