Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HOE901-U300 · 4 trials · 2 indications
Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.
| Arm | Type | Description |
|---|---|---|
| HOE901-U300 | EXPERIMENTAL | HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). |
| Lantus | ACTIVE_COMPARATOR | Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL). |
| HOE901-U300 Morning Then Evening | EXPERIMENTAL | HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L). |
| HOE901-U300 Evening Then Morning | EXPERIMENTAL | HOE901-U300 (new insulin glargine 300 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L. |
| Lantus Morning Then Evening | ACTIVE_COMPARATOR | Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L. |
| Lantus Evening Then Morning | ACTIVE_COMPARATOR | Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L. |
| Name | Type | Description |
|---|---|---|
| HOE901-U300 (Insulin glargine new formulation) | DRUG | - |
| Lantus (Insulin glargine) | DRUG | - |
| HOE901-U300 (new formulation of insulin glargine) | DRUG | HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). |
Inclusion criteria: * Adult participants with type 1 diabetes mellitus Exclusion criteria: * HbA1c less than (\<) 7.0% (53 mmol/mol) or greater than (\>) 10% (86 mmol/mol) at screening * Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visi...
HOE901-U300 is an investigational new formulation of insulin glargine being developed for the treatment of Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. It is intended for use as a basal insulin in combination with mealtime insulin or non-insulin antidiabetic therapy.
HOE901-U300 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate this new formulation of insulin glargine in patients with Type 1 and Type 2 diabetes.
HOE901-U300 is in Phase 3 clinical development. Sanofi has completed multiple Phase 3 trials comparing this new formulation of insulin glargine with Lantus in patients with Type 1 and Type 2 diabetes. The drug is investigational and has not been approved by regulatory authorities.
HOE901-U300 has been studied in several completed clinical trials, including NCT01499082 and NCT01676220 in Type 2 diabetes, and NCT01658579 and NCT01683266 in Type 1 diabetes. These trials compared the new formulation with Lantus in patients on basal plus mealtime insulin or non-insulin antidiabetic therapy.
HOE901-U300 is a new formulation of insulin glargine, the same active ingredient as Lantus. Clinical trials have been conducted to compare HOE901-U300 directly with Lantus in patients with Type 1 and Type 2 diabetes to evaluate their effects on glycemic control.