Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Insulin aspart SAR341402 · 2 trials · 1 indication
AUClast was defined as area under the plasma concentration versus time curve from time zero to last measurable timepoint. Insulin aspart was the active ingredient of SAR341402 and NovoLog.
AUC was defined as area under the concentration versus time curve. Insulin aspart is the active ingredient of SAR341402 and NovoLog.
Cmax was defined as the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog.
Number of patients with infusion set occlusions. Infusions set occlusions are defined as infusion set change due to failure to correct hyperglycemia (plasma glucose ≥ 250 mg/dL \[13.9 mmol/L\]) by insulin bolus via the insulin pump.
| Arm | Type | Description |
|---|---|---|
| Switching: NovoLog/SAR341402 | EXPERIMENTAL | Participants self-administered subcutaneous (SC) injection daily prior to the start of a meal during the 16-week treatment period, starting with NovoLog (100 units per milliliters \[U/mL\]) for the first 4 weeks, then SAR341402 (100 U/mL) for 4 weeks, followed by NovoLog (at same dose) for 4 weeks and then SAR341402 (at same dose) for the last 4 weeks on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
| Non-Switching: NovoLog | ACTIVE_COMPARATOR | Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
| SAR341402/NovoLog | EXPERIMENTAL | SAR341402 will be self-administered via continuous subcutaneous insulin infusion via an insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion. After 4 weeks of SAR341402 as treatment, patient will switch with NovoLog® as treatment. |
| NovoLog/SAR341402 | EXPERIMENTAL | Novolog will be self-administered via continuous subcutaneous insulin infusion via an insulin pump. The dose will be individually titrated and administered in a basal and bolus fashion. After 4 weeks of NovoLog® as treatment, patient will switch with SAR341402 as treatment. |
| Name | Type | Description |
|---|---|---|
| Insulin Aspart SAR341402 | DRUG | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| Insulin Aspart | DRUG | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| Insulin glargine U100 | DRUG | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
Inclusion criteria: * Participants with T1DM. * Participants on continuous insulin treatment for at least 12 months prior to screening. * Participants exclusively on a multiple (greater than or equal to 3) daily injection insulin analogue regimen using: * NovoLog as mealtime insulin for at least...
Insulin aspart SAR341402 is an investigational insulin aspart product developed by Sanofi for the treatment of Type 1 Diabetes Mellitus. It is a small molecule that acts as an agonist at the insulin receptor (INSR). The drug has been studied in Phase 3 clinical trials and is not yet approved.
Insulin aspart SAR341402 is being developed for the treatment of Type 1 Diabetes Mellitus. It is intended to provide mealtime insulin coverage, similar to other rapid-acting insulin analogs. The clinical program has focused on adults with Type 1 Diabetes Mellitus who also use insulin glargine.
Insulin aspart SAR341402 targets the insulin receptor (INSR). It acts as an agonist at this receptor, mimicking the action of endogenous insulin to facilitate glucose uptake. This mechanism is consistent with its intended use in Type 1 Diabetes Mellitus.
Insulin aspart SAR341402 is being developed by Sanofi, a global pharmaceutical company. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY. The company has conducted Phase 3 and Phase 1 trials of this investigational insulin aspart product.
Insulin aspart SAR341402 is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. Two trials have been completed: a Phase 3 trial and a Phase 1 trial, both in patients with Type 1 Diabetes Mellitus.
Insulin aspart SAR341402 has been studied in two completed clinical trials. The Phase 3 trial, NCT03874715, compared SAR341402 to NovoLog in adults with Type 1 Diabetes Mellitus also using insulin glargine, enrolling 210 patients. The Phase 1 trial, NCT03436498, assessed safety in continuous subcutaneous insulin infusion, enrolling 45 patients.