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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02273180 | Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine | PHASE3 | COMPLETED | 507 | — | — | Oct 1, 2014 | Jul 1, 2016 | Jan 18, 2018 | 89 | United States, France +6 |
| NCT02603510 | Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous Insulin Infusion | PHASE1 | COMPLETED | 27 | — | — | Nov 1, 2015 | Apr 1, 2016 | May 19, 2016 | 2 | United States |
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26.
| Arm | Type | Description |
|---|---|---|
| SAR342434 | EXPERIMENTAL | SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52. |
| Humalog | ACTIVE_COMPARATOR | Humalog before meals intake on top of QD Insulin Glargine, up to Week 52. |
| SAR342434/Humalog | EXPERIMENTAL | SAR342434 and Humalog will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion. |
| Humalog/SAR342434 | EXPERIMENTAL | Humalog and SAR342434 will be self-administered subcutaneously via insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion. |
| Name | Type | Description |
|---|---|---|
| SAR342434 | DRUG | SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by deep subcutaneous (SC) injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour post prandial plasma glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia. |
| Humalog | DRUG | Humalog 100 U/mL (dose range of 1 unit to 60 units) self-administered by deep SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycaemia. |
| 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 (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia. |
| insulin lispro | DRUG | Pharmaceutical form:solution Route of administration: subcutaneous |
Inclusion criteria: * Participants with T1DM diagnosed for at least 12 months and had been treated with insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before each meal) in the 6 months prior to the screening visit. * Written informed consent. Exclusion criteria: * At...