Study S001958

Pharmacokinetics, Safety and Immunogenicity of 14028 Injection Versus Dulaglutide Injection in Healthy Subjects: a Phase I ，Single-center, Randomized, Open-label, Single-dose, Parallel-controlled Clinical Study

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: NCT05459285
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 68
Start: 2022-05-31
Primary completion: 2022-07-02
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: BIOLOGICAL:14028 injection; BIOLOGICAL:dulaglutide injection
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Maximum (peak) plasma drug concentration(Cmax) [0 hour (pre-dose,within 30mins) to 384 hours after administration]
Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞) [0 hour (pre-dose, within 30mins) to infinity]

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
R0012664	A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity®) in healthy Chinese subjects. Gao X, Clinical and translational science	2024	Randomized trial	PMID 38651744 DOI	cites ClinicalTrials.gov:NCT05459285; registry reference DERIVED:38651744
R0011520	No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide. de la Peña A, Clinical pharmacokinetics	2017	Other trial	PMID 28357715 DOI	registry reference BACKGROUND:28357715
R0014641	Clinical Pharmacokinetics of Dulaglutide in Patients with Type 2 Diabetes: Analyses of Data from Clinical Trials. Geiser JS, Clinical pharmacokinetics	2016	Other trial	PMID 26507721 DOI	registry reference BACKGROUND:26507721
R0021934	LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects. Barrington P, Diabetes, obesity & metabolism	2011	Randomized trial	PMID 21251179 DOI	registry reference BACKGROUND:21251179
R0024392	A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes. Barrington P, Diabetes, obesity & metabolism	2011	Randomized trial	PMID 21251178 DOI	registry reference BACKGROUND:21251178