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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02752828 | Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan | PHASE3 | COMPLETED | 521 | — | — | May 23, 2016 | Mar 12, 2018 | Jun 16, 2020 | 113 | Japan |
| Arm | Type | Description |
|---|---|---|
| LixiLan | EXPERIMENTAL | LixiLan (insulin glargine/lixisenatide) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. |
| insulin glargine | ACTIVE_COMPARATOR | Insulin glargine (HOE901) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. |
| Name | Type | Description |
|---|---|---|
| Insulin glargine/lixisenatide (HOE901/AVE0010) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin glargine (HOE901) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Oral anti-diabetic drugs | DRUG | Pharmaceutical form: tablet Route of administration: oral |
Inclusion criteria : * Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be Biguanide,Thiazolidinedione (TZD), -Alpha-glucosidase-inhibitor (alpha-GI),Sodium glucose co-transporter 2 (SGLT2) inhibitor,Sulfonylurea (...