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Combination Drug

Insulin glargine/Lixisenatide for Diabetes (Soli-CGM Trial)

Phase 4
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (days -14 to -1) and week 16
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial tests if a new treatment can better control blood sugar in people with very high levels of type 2 diabetes who are not responding well to their current medications. The treatment combines insulin with another drug to help manage blood sugar more effectively.

Eligible Conditions
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (days -14 to -1) and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (days -14 to -1) and week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]
Secondary study objectives
Change From Baseline to Week 16 in Mean Daily Blood Glucose
Change From Baseline to Week 16 in Overall Score of Diabetes Medication Treatment Satisfaction Scores Using the Diabetes Medication Satisfaction Tool (DM-SAT) Questionnaire
Change From Baseline to Week 16 in Time Above Range (>180 mg/dL)
+10 more

Side effects data

From 2023 Phase 4 trial • 124 Patients • NCT05114590
6%
Hypoglycaemia
6%
Upper Respiratory Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
iGlarLixi

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: iGlarLixiExperimental Treatment1 Intervention
iGlarLixi (i.e., insulin glargine 100 Units/ml /lixisenatide 33 μg/mL) once daily for 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin glargine/Lixisenatide
2022
Completed Phase 4
~710

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,197 Previous Clinical Trials
4,035,189 Total Patients Enrolled
19 Trials studying Diabetes
20,597 Patients Enrolled for Diabetes
Clinical Sciences & OperationsStudy DirectorSanofi
871 Previous Clinical Trials
2,020,836 Total Patients Enrolled
1 Trials studying Diabetes
4,589 Patients Enrolled for Diabetes
~33 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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