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Insulin glargine/Lixisenatide
This fixed-dose combination provides basal insulin coverage via insulin glargine while lixisenatide, a GLP-1 receptor agonist, enhances glucose-dependent insulin secretion and reduces appetite.
This fixed-dose combination provides basal insulin coverage via insulin glargine while lixisenatide, a GLP-1 receptor agonist, enhances glucose-dependent insulin secretion and reduces appetite. Used for Type 2 diabetes mellitus (as add-on to oral antidiabetic agents or as basal-bolus therapy).
At a glance
| Generic name | Insulin glargine/Lixisenatide |
|---|---|
| Also known as | Soliqua 100/33, HOE901/AVE0010, iGlarLixi, AVE0010-1 |
| Sponsor | Sanofi |
| Drug class | Insulin/GLP-1 receptor agonist combination |
| Target | Insulin receptor; GLP-1 receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | FDA-approved |
Mechanism of action
Insulin glargine is a long-acting basal insulin that provides steady background glucose control by mimicking endogenous insulin secretion. Lixisenatide is a short-acting GLP-1 receptor agonist that stimulates insulin release in response to meals, slows gastric emptying, and promotes satiety. Together, they address both fasting and postprandial hyperglycemia in type 2 diabetes.
Approved indications
- Type 2 diabetes mellitus (as add-on to oral antidiabetic agents or as basal-bolus therapy)
Common side effects
- Hypoglycemia
- Nausea
- Vomiting
- Diarrhea
- Injection site reactions
- Headache
Key clinical trials
- iGlarLixi CGM Study in Chinese T2D Individuals After OADs (PHASE4)
- Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes (PHASE4)
- A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus (PHASE4)
- Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents (PHASE4)
- Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
- iGlarLixi vs IDegAsp in Chinese Participants After OAD(s) (PHASE3)
- Evaluation of the Efficacy and Safety of GLP-1 Receptor Agonist Therapy In Steroid-Induced Diabetes (PHASE4)
- Effect of Soliqua 100/33 on Time in Range From Continuous Glucose Monitoring in Insulin-naive Patients With Very Uncontrolled Type 2 Diabetes Mellitus (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Insulin glargine/Lixisenatide CI brief — competitive landscape report
- Insulin glargine/Lixisenatide updates RSS · CI watch RSS
- Sanofi portfolio CI