Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NovoLog/NovoRapid · 1 trial · 1 indication
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) ...
NovoLog/NovoRapid is an investigational small molecule being studied for the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is being evaluated in adult patients who are also using insulin glargine. The drug is in Phase 3 clinical development and is not yet approved.
NovoLog/NovoRapid is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in patients with diabetes mellitus.
NovoLog/NovoRapid is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a completed Phase 3 trial involving adult patients with Type 1 or Type 2 Diabetes Mellitus.
NovoLog/NovoRapid has been studied in one completed Phase 3 clinical trial with the identifier NCT03211858. The trial, titled 'Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine,' enrolled 597 participants across multiple countries including the United States, Finland, Germany, Hungary, Japan, Poland, and Russia.
Yes, NovoLog/NovoRapid is also known as SAR341402. In the clinical trial NCT03211858, the drug is referred to as SAR341402, and it is being compared to NovoLog/NovoRapid. This alternative name is used in the study title and documentation.