Study S002081

A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

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

Registration

Registration: NCT03353350
Acronym: AMPLITUDE-M
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 406
Start: 2017-12-05
Primary completion: 2020-01-29
Lead sponsor: Hanmi Pharmaceutical Company Limited
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:efpeglenatide (SAR439977); DRUG:placebo
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:2016-001857-42; OTHER:U1111-1182-1806; NIH:2016

Registered primary outcomes

Change in Glycated Hemoglobin (HbA1c) (%) [Baseline to Week 30]

Linked records (1)

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
R0007136	Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. Frias JP, Diabetes care	2022	Randomized trial	PMID 35671039 DOI	cites ClinicalTrials.gov:NCT03353350; registry reference DERIVED:35671039