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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03211858 | Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine | PHASE3 | COMPLETED | 597 | — | — | Aug 2, 2017 | Jan 12, 2019 | Mar 28, 2022 | 82 | United States, Finland +5 |
All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained from the multiple imputations (results were combined using Rubin's formulae).
| Arm | Type | Description |
|---|---|---|
| SAR341402 | EXPERIMENTAL | SAR341402 subcutaneous (SC), before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52. |
| NovoLog/NovoRapid | ACTIVE_COMPARATOR | NovoLog/NovoRapid SC, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| Name | Type | Description |
|---|---|---|
| Insulin aspart | DRUG | SAR341402 100 units per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG \<10 millimoles/liter \[mmol/L\] \[\<180 milligram/deciliter {mg/dL}\]) while avoiding hypoglycemia. |
| NovoLog/NovoRapid | DRUG | NovoLog/NovoRapid 100 U/mL (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG \<10 mmol/L \[\<180 mg/dL\]) while avoiding hypoglycemia. |
| Insulin glargine (HOE901) | DRUG | Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia. |
Inclusion criteria : * Participants with T1DM or T2DM (T2DM US only) diagnosed for at least 12 months, who have been treated with a multiple daily injection regimen with * NovoLog/NovoRapid or insulin lispro (100 U/mL) in the last 6 months prior to screening visit AND * insulin glargine (100 U/mL) ...