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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00553488 | Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating | PHASE2 | COMPLETED | 30 | — | — | Sep 1, 2007 | Jan 1, 2008 | Aug 22, 2008 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Regular insulin SC at -17 mins |
| 2 | ACTIVE_COMPARATOR | Regular insulin ID at -17 mins |
| 3 | ACTIVE_COMPARATOR | Regular insulin ID at -2 mins |
| 4 | ACTIVE_COMPARATOR | Insulin lispro given SC at -2 mins |
| 5 | EXPERIMENTAL | Insulin lispro given ID at -2 mins |
| Name | Type | Description |
|---|---|---|
| Regular insulin (Humulin) | DRUG | Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days. |
| Insulin lispro (Humalog) | DRUG | Insulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days. |
Inclusion Criteria: * Type 1 diabetes for 1-15 years, on multiple daily injections (MDI) or insulin pump (CSII) in stable control with HbA1c \<= 9.0%. * Able to attend clinic for 5 different days Exclusion Criteria: * BMI \> 32 kg/m2 * Evidence of gastroparesis or impaired renal function or lipod...