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Combination Drug

Insulin glargine/Lixisenatide for Type 2 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 up to end of study (week 18)
Awards & highlights

Soli-CGM Trial Summary

This trial is testing if a new medication, Soliqua 100/33, can improve glycemic control in people with uncontrolled type 2 diabetes who are already taking 2 other diabetes medications. It will last 22 weeks and there will be 3 in-person visits and up to 13 phone contacts.

Eligible Conditions
  • Type 2 Diabetes

Soli-CGM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to end of study (week 18)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of study (week 18) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to week 16 in the percentage of Time in Range (TIR)
Secondary outcome measures
Change from baseline to Week 16 in TIR per time blocks
Change from baseline to Week 16 in Time above range (TAR)
Change from baseline to Week 16 in Time to reach maximum PPG concentration (Tmax)
+10 more

Soli-CGM Trial Design

1Treatment groups
Experimental Treatment
Group I: Soliqua 100/33Experimental Treatment1 Intervention
Soliqua 100/33 (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
~660

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,408 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,227 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently vacancies for prospective participants in this research?

"Indeed, according to clinicaltrials.gov the trial is still seeking recruits. The original announcement was made on January 27th 2022 and then revised most recently September 29th 2022. Currently, 100 patients are being accepted at 39 sites across the country."

Answered by AI

What have clinical trials revealed about the efficacy of Insulin glargine/Lixisenatide?

"Insulin glargine/Lixisenatide is regularly utilized to reduce hyperglycemia and can be therapeutically prescribed for various other conditions such as type 2 diabetes mellitus, exercise-related insulin deficiency, and insulin detemir."

Answered by AI

What potential risks could be associated with taking Insulin glargine/Lixisenatide?

"The combination of insulin glargine and lixisenatide's safety rating was appraised as 3 due to this being a Phase 4 trial, which indicates that the treatment has been authorised for use."

Answered by AI

How many individuals have registered for this clinical experiment?

"Affirmative. The details on clinicaltrials.gov denote that this experiment is actively recruiting participants, which began on 27th January 2022 and was last updated 29th September 2022. 100 individuals are being sought from 39 trial sites across the country."

Answered by AI

How many sites have been selected to conduct this experiment?

"This trial is recruiting 39 patients from various sites around the globe. These include Downtown LA Research Center Inc - Clinedge - PPDS-Site Number:8400001 in Los Angeles, National Research Institute - ClinEdge - PPDS-Site Number:8400004 in Berlin, and Hassman Research Institute - HRI - Berlin - CenExel - PPDS-Site Number:8400007 in New Windsor, as well as 36 other locations."

Answered by AI

Are there any prior investigations that have focused on Insulin glargine/Lixisenatide?

"Presently, there are 13 studies that explore Insulin glargine/Lixisenatide. Of those projects, 4 are in the advanced Phase 3 stage of research. The majority of trials take place in Cincinnati, Ohio; however, 208 other sites around the world host these investigations."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
65+
18 - 65
What site did they apply to?
University of Texas Southwestern Medical Center-Site Number:8400018
National Research Institute - ClinEdge - PPDS-Site Number:8400004
Palm Research Center, Inc.-Site Number:8400005
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus
2022. "Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05114590.
~23 spots leftby Apr 2025
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