Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus

(Soli-CGM Trial)

Recruiting at 40 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sanofi

Must be taking: Oral antidiabetics

Must not be taking: Meglitinides, Insulin, Prednisone

Disqualifiers: Type 1 diabetes, BMI >40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You will need to stop taking any daily or weekly GLP-1 RA or DPP 4i medications before starting the trial medication, iGlarLixi (Soliqua 100/33). The protocol does not specify changes for other medications, but you should discuss this with the trial team.

How is the drug Insulin glargine/Lixisenatide unique for treating type 2 diabetes?

Insulin glargine/Lixisenatide is unique because it combines a long-acting insulin (insulin glargine) with a GLP-1 receptor agonist (lixisenatide) in a single daily injection, helping to control blood sugar levels without causing weight gain and with a low risk of low blood sugar episodes. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Insulin glargine/Lixisenatide?

Research shows that the combination of insulin glargine and lixisenatide helps more patients with type 2 diabetes achieve better blood sugar control compared to using insulin alone or other oral diabetes medications. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosed with Type 2 Diabetes mellitus (T2DM) for at least 6 months before the baseline period

HbA1c ≥9-13% during the run-in period

On at least 2 OADs with or without GLP-1 RA with stable doses (for both) for 3 months prior to the screening period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in

Participants undergo a run-in period to establish baseline measurements

2 weeks

1 visit (in-person or home)

Treatment

Participants receive iGlarLixi (Soliqua 100/33) once daily to improve glycemic control

16 weeks

3 site visits, up to 13 phone contacts

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person or home)

What Are the Treatments Tested in This Trial?

Interventions

• Insulin glargine/Lixisenatide

How Is the Trial Designed?

Group I: iGlarLixi Experimental Treatment 1 Intervention

iGlarLixi (i.e., insulin glargine 100 Units/ml /lixisenatide 33 μg/mL) once daily for 16 weeks.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

1. England pubmed.ncbi.nlm.nih.gov

Real-world evidence on the use of a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) in people with suboptimally controlled type 2 diabetes in Romania: a prospective cohort study (STAR.Ro). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

More patients reach glycaemic control with a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) than with basal insulin at 12 weeks of treatment: A post hoc time-to-control analysis of LixiLan-O and LixiLan-L. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Switch to Combined GLP1 Receptor Agonist Lixisenatide with Basal Insulin Glargine in Poorly Controlled T2DM Patients with Premixed Insulin Therapy: A Clinical Observation and Pilot Study in Nine Patients. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Lixisenatide and Insulin Glargine, Versus Insulin Glargine in Type 2 Diabetes Inadequately Controlled on Metformin Monotherapy: The LixiLan Proof-of-Concept Randomized Trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Impact of lixisenatide dose range on clinical outcomes with fixed-ratio combination iGlarLixi in patients with type 2 diabetes. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of once daily GLP-1 receptor agonist lixisenatide compared to bolus insulin both in combination with basal insulin for the treatment of patients with type 2 diabetes in Norway. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

iGlarLixi: A Fixed-Ratio Combination of Insulin Glargine 100 U/mL and Lixisenatide for the Treatment of Type 2 Diabetes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness, Safety, and Appropriateness in the Use of the Fixed-Ratio Combination of Insulin Glargine and Lixisenatide in Type 2 Diabetes: The ENSURE Retrospective Real-World Study. [2023]