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SAR342434 · 4 trials · 3 indications
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 6-month period and adequate contrasts at Week 26.
| Arm | Type | Description |
|---|---|---|
| SAR342434 | EXPERIMENTAL | SAR342434 100 Unit/mL (U/mL) before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26. |
| Humalog | ACTIVE_COMPARATOR | Humalog 100 U/mL before meals intake on top of QD Insulin Glargine, up to Week 26. |
| 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. |
| Test (T) | EXPERIMENTAL | SAR342434: single dose injection |
| Reference 1 (R1) | ACTIVE_COMPARATOR | US-approved Humalog®: single dose injection |
| Reference 2 (R2) | ACTIVE_COMPARATOR | EU-approved Humalog®: single dose injection |
| Name | Type | Description |
|---|---|---|
| SAR342434 | DRUG | SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by subcutaneous (SC) injection, immediately (within 5 -10 minutes) before meals intake. Dose adjusted to achieve 2 hour post prandial 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 SC injection, immediately (within 5-10 minutes) before meals 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 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 (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 T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit. * Signed written informed consent. Exclusion criter...
SAR342434 is an investigational rapid-acting insulin being studied for the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is developed as a potential alternative to existing rapid-acting insulins like Humalog (insulin lispro) for managing blood sugar levels in adult patients.
SAR342434 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational insulin product.
SAR342434 is in Phase 1 clinical development. While some completed trials were Phase 3 studies, the overall development program includes Phase 1 trials. The drug is investigational and not yet approved by regulatory authorities. It remains in clinical development for diabetes indications.
SAR342434 has been studied in several completed clinical trials. Key studies include NCT02273180 and NCT02294474, which compared SAR342434 to Humalog in patients with Type 1 and Type 2 Diabetes, and NCT02273258, a pharmacokinetic study. All trials listed are completed.
SAR342434 is being compared to insulin lispro (Humalog) in clinical trials, but it is a distinct investigational product. It is designed to act as a rapid-acting insulin similar to insulin lispro, though it has not been established as identical to or interchangeable with Humalog.