Study S000695

A 26-week Randomized, Open-label, Active-controlled, 2-treatment Arm, Parallel Group Multi-center Study, Comparing the Efficacy and Safety of Soliqua™100/33 Versus Lantus® in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

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

Registration

Registration: NCT03434119
Acronym: LixiLan-D
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: TERMINATED
Enrollment: 241
Start: 2018-02-20
Primary completion: 2019-01-07
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Insulin glargine/Lixisenatide; DRUG:Insulin glargine (HOE901); DRUG:Background therapy
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1200-1891

Registered primary outcomes

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 [Baseline, Week 26]

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