Study S001954

A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics

ClinicalTrials.gov record

Registration

Registration: NCT06671587
Acronym: China Soli-CGM
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: RECRUITING
Enrollment: 678
Start: 2024-12-10
Primary completion: 2026-09-18
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes (T2D)
Interventions: DRUG:iGlarLixi (insulin glargine/lixisenatide); DRUG:Gla-100 (insulin glargine)
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: REGISTRY:U1111-1306-6660

Registered primary outcomes

Superiority of mean change in the percentage of TIR [3.9-10.0 mmol/L (70-180 mg/dL)] [from baseline to Week 20]

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