Study S001123

A Phase III, Randomized, Parallel, Double-blind, and Non-inferiority Clinical Trial to Compare Efficacy and Safety of CinnaGen-liraglutide to Innovator Liraglutide Product (Victoza®) in Patients With Type II Diabetes (T2D)

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT03421119
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: TRIPLE
Status: UNKNOWN
Enrollment: 300
Start: 2019-06-20
Primary completion: 2019-12-01
Lead sponsor: Cinnagen
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Liraglutide 6 MG/ML Pen Injector; DRUG:Metformin; DRUG:Sulfonylurea/non-sulfonylurea insulin secretagogues
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

HbA1c [26 weeks]

Linked records (6)

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
R0013081	Efficacy and Safety of a Biosimilar Liraglutide (Melitide®) Versus the Reference Liraglutide (Victoza®) in People with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Noninferiority Clinical Trial. Esteghamati A, Diabetes therapy : research, treatment and education of diabetes and related disorders	2023	Randomized trial	PMID 37707701 DOI	cites ClinicalTrials.gov:NCT03421119; registry reference DERIVED:37707701
R0017606	Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Zinman B, Diabetes care	2009	Randomized trial	PMID 19289857 DOI	registry reference BACKGROUND:19289857
R0019848	Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Nauck M, Diabetes care	2009	Randomized trial	PMID 18931095 DOI	registry reference BACKGROUND:18931095
R0020382	Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Buse JB, Lancet (London, England)	2009	Randomized trial	PMID 19515413 DOI	registry reference BACKGROUND:19515413
R0026073	Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Marre M, Diabetic medicine : a journal of the British Diabetic Association	2009	Randomized trial	PMID 19317822 DOI	registry reference BACKGROUND:19317822
R0027336	Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Russell-Jones D, Diabetologia	2009	Randomized trial	PMID 19688338 DOI	registry reference BACKGROUND:19688338