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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 by Sanofi (SNY) and is intended for use in adult patients, often in combination with insulin glargine. The drug is currently in clinical development.
SAR342434 is developed by Sanofi, a multinational pharmaceutical company traded under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's efficacy and safety in patients with Type 1 and Type 2 diabetes. The drug is in Phase 1 and Phase 3 clinical trials.
SAR342434 is in Phase 1 and Phase 3 clinical trials. The Phase 1 trials focus on pharmacokinetics, pharmacodynamics, and safety, while Phase 3 trials compare its efficacy to Humalog in patients with Type 1 and Type 2 diabetes. All trials listed are completed.
SAR342434 has been studied in several completed clinical trials, including NCT02273180 (Phase 3, Type 1 Diabetes), NCT02273258 (Phase 1, Type 1 Diabetes), NCT02294474 (Phase 3, Type 2 Diabetes), and NCT02603510 (Phase 1, Type 1 Diabetes). These trials enrolled a total of 534 participants.
SAR342434 is being compared to insulin lispro (Humalog) in clinical trials. It is a rapid-acting insulin, but it is not stated to be the same as insulin lispro. The trials assess whether SAR342434 can be used as an alternative to Humalog in diabetes management.
SAR342434 is an investigational drug in clinical development by Sanofi. It has completed Phase 1 and Phase 3 trials, but it is not approved by regulatory authorities. The drug is being evaluated for safety and efficacy in treating Type 1 and Type 2 diabetes.