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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01486940 | Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes | PHASE3 | COMPLETED | 598 | — | — | Mar 1, 2002 | Oct 1, 2002 | Jan 27, 2017 | 75 | Argentina, Croatia +13 |
| NCT01707134 | Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes | PHASE3 | COMPLETED | 753 | — | — | Sep 1, 1997 | May 1, 2000 | Jan 4, 2017 | 80 | Austria, Denmark +6 |
| NCT02162407 | A Trial Investigating the Relationship Between Pharmacodynamic and Interstitial Concentration for Insulin Detemir and Human Insulin | PHASE1 | COMPLETED | 13 | — | — | Oct 1, 1999 | Dec 1, 1999 | Jun 12, 2014 | 1 | Austria |
| Arm | Type | Description |
|---|---|---|
| Basal/bolus regimen 1 | EXPERIMENTAL | - |
| Basal/bolus regimen 2 | ACTIVE_COMPARATOR | - |
| insulin aspart | EXPERIMENTAL | - |
| human insulin | ACTIVE_COMPARATOR | - |
| Insulin detemir 60 pmol/kg/min | EXPERIMENTAL | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Insulin detemir 120 pmol/kg/min | EXPERIMENTAL | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Human insulin 6 pmol/kg/min | ACTIVE_COMPARATOR | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Name | Type | Description |
|---|---|---|
| insulin detemir | DRUG | Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily |
| insulin aspart | DRUG | Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals |
| insulin NPH | DRUG | Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily |
| human soluble insulin | DRUG | Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals |
Inclusion Criteria: * Type 1 diabetes for at least 12 months * Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months * BMI below or equal to 35 kg/m\^2 * HbA1c below or equal to 12% Exclusion Criteria: * Proliferative retinopathy or maculopathy req...