Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HOE901-U300 (new formulation of insulin glargine), HOE901-U300 (Insulin glargine new formulation), Toujeo
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 developed by Sanofi for the treatment of type 1 diabetes mellitus and type 2 diabetes mellitus. It is a small molecule in Phase 3 clinical development and has been studied in four completed trials with a combined enrollment of 1,685 participants.
HOE901-U300 is being developed for glycemic control in type 1 diabetes mellitus and type 2 diabetes mellitus. Its clinical program includes patients with type 1 diabetes on basal plus mealtime insulin and patients with type 2 diabetes on non-insulin antidiabetic therapy or basal plus mealtime insulin.
Sanofi, which trades under the ticker SNY, is the developer of HOE901-U300. The company sponsors the clinical program evaluating this new insulin glargine formulation in type 1 and type 2 diabetes mellitus.
HOE901-U300 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The program includes completed Phase 3 trials in type 1 and type 2 diabetes mellitus, plus one completed Phase 2 trial in type 1 diabetes.
Four completed trials have evaluated HOE901-U300: NCT01683266 and NCT01658579 in type 1 diabetes mellitus, and NCT01676220 and NCT01499082 in type 2 diabetes mellitus. The Phase 3 studies compared the new insulin glargine formulation with Lantus and enrolled 549, 878, and 807 patients respectively.
HOE901-U300 is a new formulation of insulin glargine, so it contains the same active ingredient in a different formulation rather than being an unrelated compound. It is also referred to as HOE901-U300 (new formulation of insulin glargine) and HOE901-U300 (insulin glargine new formulation).