Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05413369 | iGlarLixi vs IDegAsp in Chinese Participants After OAD(s) | PHASE3 | COMPLETED | 582 | — | — | Jul 7, 2022 | Oct 20, 2023 | Sep 24, 2025 | 60 | China |
Blood samples were collected at indicated timepoints for analysis of HbA1c. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
| Arm | Type | Description |
|---|---|---|
| iGlarLixi | EXPERIMENTAL | Participants self-administered iGlarLixi (100 units per milliliter \[U/mL\] insulin glargine + 100 or 50 microgram \[mcg\]/mL lixisenatide respectively) subcutaneous (SC) injection once daily on top of metformin +/- sodium-glucose co-transporter 2 inhibitor (SGLT-2i) for 24 weeks. Dose was individually adjusted. |
| IDegAsp | ACTIVE_COMPARATOR | Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted. |
| Name | Type | Description |
|---|---|---|
| Insulin glargine/Lixisenatide | DRUG | solution, by subcutaneous injection |
| IDegAsp | DRUG | solution, by subcutaneous injection |
| Metformin | DRUG | Tablet, orally |
| SGLT2 inhibitor | DRUG | Tablet, orally |
Inclusion Criteria: * Participant had at least 18 of age inclusive, at the time of signing the informed consent. * Participants who were diagnosed with T2DM for at least 1 year before the screening visit * Participants who were treated for at least 3 months prior to the screening visit with a stabl...