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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02562326 | A Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 51 | — | — | Sep 1, 2015 | Jan 1, 2016 | Apr 29, 2016 | 2 | Germany |
Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro)
Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro)
| Arm | Type | Description |
|---|---|---|
| BioChaperone insulin lispro | EXPERIMENTAL | - |
| Humalog® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BioChaperone insulin lispro | DRUG | Injection immediately before the start of the individualised standard meal |
| Humalog® | DRUG | Injection immediately before the start of the individualised standard meal |
Inclusion Criteria: * Type 2 diabetes mellitus ≥ 12 months * Treated with stable multiple daily insulin ≥ 3 months (basal-bolus therapy or only bolus insulin therapy) * Current total daily insulin treatment \<1.2 (I)U/kg/day * Body Mass Index below or equal to 40.0 kg/m² * HbA1c ≤ 9.0% by local lab...