Study S002030

A 16-week, Multicenter, Prospective, Open-label, Single-arm, Phase 4 Study to Evaluate the Effect of Soliqua™ 100/33 on the Percentage of Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Insulin-naïve Patients With Very Uncontrolled Type 2 Diabetes Mellitus

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

Registration

Registration: NCT05114590
Acronym: Soli-CGM
Study type: INTERVENTIONAL
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 124
Start: 2022-01-27
Primary completion: 2023-03-28
Lead sponsor: Sanofi
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Insulin glargine/Lixisenatide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: REGISTRY:U1111-1261-7399

Registered primary outcomes

Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)] [Baseline (Days -14 to -1) and Week 16]

Linked records (4)

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
R0004264	Effect of iGlarLixi on continuous glucose monitoring-measured time in range in insulin-naive adults with suboptimally controlled type 2 diabetes. Frías JP, Diabetes, obesity & metabolism	2025	Other trial	PMID 39905643 DOI	cites ClinicalTrials.gov:NCT05114590
R0039387	24-PUB: The Efficacy and Safety of iGlarLixi in Insulin-Naïve Adults with Type 2 Diabetes (T2D) by Baseline Age, Sodium–Glucose Cotransporter 2 Inhibitor (SGLT2i) Use, and BMI—Post Hoc Analysis of Soli-CGM Viral N. Shah, Diabetes	2025	Other trial	DOI	cites ClinicalTrials.gov:NCT05114590
R0051813	839-P: Treatment Satisfaction and Time in Range (TIR) after 16 Weeks of iGlarLixi in Insulin-Naive Adults with Suboptimally Controlled Type 2 Diabetes Viral N. Shah, Diabetes	2024	Other trial	DOI	cites ClinicalTrials.gov:NCT05114590
R0052929	374-P: Impact of Sulfonylurea (SU) Use on Hypoglycemia and Continuous Glucose Monitoring (CGM) Metrics after 16 Weeks of iGlarLixi in Insulin-Naïve Adults with Type 2 Diabetes (T2D) and Mean A1C >10% ALEXANDRIA RATZKI-LEEWING, Diabetes	2024	Other trial	DOI	cites ClinicalTrials.gov:NCT05114590