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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02855684 | Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy | PHASE3 | COMPLETED | 604 | — | — | Aug 24, 2016 | Aug 6, 2018 | Apr 25, 2022 | 54 | China, South Korea +1 |
| Arm | Type | Description |
|---|---|---|
| Toujeo - insulin glargine (U300) | EXPERIMENTAL | Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks |
| Lantus - insulin glargine | ACTIVE_COMPARATOR | Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks |
| Name | Type | Description |
|---|---|---|
| Insulin glargine (U300) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin glargine | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Non-insulin antihyperglycemic drugs | DRUG | Pharmaceutical form: capsule/tablet Route of administration: oral |
Inclusion criteria : * Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s). * Signed written informed consent. Exclusion criteria: * Age \< legal age of adulthood. * HbA1c \<7.0% (\<53 mmol/mol) or \>11% (\>97 mmol/mol) (at screening). *...