Soliqua 100/33 for Type 2 Diabetes

(Soli-CGM Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a daily injection called iGlarLixi (Soliqua 100/33) helps individuals with very uncontrolled type 2 diabetes manage their blood sugar levels. The goal is to determine if this treatment can increase the time blood sugar remains within a healthy range, as measured by a small monitoring device. Individuals who have had type 2 diabetes for at least six months, struggle to control it with pills, and are willing to try a new injectable treatment might be suitable for this study. As a Phase 4 trial, this study involves an FDA-approved treatment, aiming to understand its benefits for more patients.

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.

What is the safety track record for this treatment?

Research has shown that iGlarLixi, a combination of insulin glargine and lixisenatide, is generally safe for people. Studies indicate that its safety profile is similar to that of the individual drugs, insulin glargine and lixisenatide, meaning it doesn't introduce new safety concerns beyond those already known.

Common side effects include low blood sugar symptoms, such as dizziness or sweating, which are typical for insulin treatments. In past studies, serious side effects were rare. Patients with type 2 diabetes have generally tolerated the combination well, with no unexpected problems reported.

The FDA has already approved this treatment for managing diabetes, suggesting it is considered safe when used under a doctor's care. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Soliqua 100/33 because it combines two powerful components: insulin glargine and lixisenatide. This combo not only helps control blood sugar levels but also targets them in a unique way. Insulin glargine provides long-lasting blood sugar control, while lixisenatide, a GLP-1 receptor agonist, enhances the body's natural insulin production and slows down digestion, making it easier to maintain stable glucose levels. Unlike standard treatments that usually involve multiple injections or medications, Soliqua 100/33 simplifies the process with a single daily injection. This innovative approach could make managing very uncontrolled type 2 diabetes much more effective and convenient for patients who haven't used insulin before.

What is the effectiveness track record for Insulin glargine/Lixisenatide in improving glycemic control in type 2 Diabetes Mellitus?

Research has shown that iGlarLixi, a combination of insulin glargine and lixisenatide, helps control blood sugar in people with type 2 diabetes. Studies have found that this treatment significantly lowers HbA1c levels, a measure of long-term blood sugar control. One study showed that patients using iGlarLixi experienced better blood sugar reductions after 30 weeks compared to other treatments. Additional research confirms that iGlarLixi is both effective and safe for people whose diabetes isn't well-managed with other medications. These findings suggest it could be a promising option for managing very uncontrolled type 2 diabetes. ^{2 6 7 8 9}

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40785322/

Long-term effectiveness of iGlarLixi treatment in people ... The primary outcome was change in HbA1c 24 months after starting iGlarLixi. Secondary outcomes included change in HbA1c from baseline, achievement of HbA1c <7%, ...

2. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16591

Long‐term effectiveness of iGlarLixi treatment in people with ... The primary outcome was change in HbA1c 24 months after starting iGlarLixi. Secondary outcomes included change in HbA1c from baseline, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38637981/

Real-world effectiveness and safety of insulin glargine 100 ... This real-world observational study shows that initiation of iGlarLixi in people with T2D inadequately controlled on oral antidiabetic drugs ± basal insulin ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1056872718306019

Efficacy and safety of insulin glargine/lixisenatide (iGlarLixi ... In both trials, older patients treated with iGlarLixi achieved significantly greater reductions in A1C at Week 30 than comparators. Treatment with iGlarLixi ...

5. link.springer.com link.springer.com/article/10.1007/s13300-024-01644-0

Real-Life Effectiveness of iGlarLixi (Insulin Glargine 100 U ... Initiation of iGlarLixi in people with uncontrolled T2D is effective and safe in clinical practice, across different baseline HbA1c and BMI categories.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6349286/

A Review of the Safety and Adverse Event Profile ... iGlarLixi has a safety profile that is consistent with that of its two active components insulin glargine and lixisenatide, with no signals for ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03798080

Comparison of the Efficacy and Safety of Insulin Glargine ... Comparison of the Efficacy and Safety of Insulin Glargine/​Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes ...

8. sanofi.com sanofi.com/assets/countries/india/docs/science-and-innovation/for-healthcare-professionals/product-information/pharmaceuticals/soliqua-solo-star-pi.pdf

Fixed ratio combination of Insulin Glargine + Lixisenatide Insulin Glargine. Non-clinical data for insulin glargine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose ...

9. diabetesjournals.org diabetesjournals.org/care/article/43/6/1249/35687/Efficacy-and-Safety-of-1-1-Fixed-Ratio-Combination

Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin ... OBJECTIVE. To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) i.