Study S001374

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 Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03713684
Acronym: AMPLITUDE-L
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: TERMINATED
Enrollment: 370
Start: 2018-11-09
Primary completion: 2020-11-20
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Efpeglenatide SAR439977; DRUG:Placebo; DRUG:Background therapy
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:U1111-1189-5009

Registered primary outcomes

Change From Baseline to Week 30 in HbA1c [Baseline to Week 30]

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