Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01683266 | Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus | PHASE3 | COMPLETED | 549 | — | — | Sep 1, 2012 | Mar 1, 2014 | Jun 24, 2015 | 147 | United States, Canada +11 |
| NCT01658579 | Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin | PHASE2 | COMPLETED | 59 | — | — | Aug 1, 2012 | May 1, 2013 | Jun 1, 2015 | 3 | United States |
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 | - |
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...