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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00698802 | Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes | PHASE2 | COMPLETED | 397 | — | — | Jun 1, 2008 | Mar 1, 2009 | Apr 14, 2015 | 3 | India, South Africa +1 |
| NCT00660374 | Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes | PHASE2 | COMPLETED | 402 | — | — | Feb 1, 2008 | Mar 1, 2009 | May 5, 2015 | 1 | Brazil |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EX1000 | DRUG | Treat-to-target titration scheme, s.c. injection |
| biphasic human insulin | DRUG | Treat-to-target titration scheme, s.c. injection |
| insulin NPH | DRUG | "Soft-treat-to-target" dose titration scheme, injection s.c. |
Inclusion Criteria: * Type 2 diabetes for at least 12 months * Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs * Body Mass Index (BMI) less than or equal to 40.0 kg/m2 * HbA1c less than or equal to 9.5% * FPG (SMPG) less th...