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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00642538 | A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 20 | — | — | Feb 1, 2008 | Sep 1, 2008 | Jun 14, 2012 | 1 | Netherlands |
| NCT00475371 | A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males | PHASE1 | COMPLETED | 26 | — | — | Apr 1, 2007 | - | Jun 14, 2012 | 1 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
| 2 | EXPERIMENTAL | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
| 3 | EXPERIMENTAL | 1.5 mg dose of GLP-1 as MKC253 Inhalation Powder |
| 4 | PLACEBO_COMPARATOR | TIP (placebo comparison) |
| 5 | ACTIVE_COMPARATOR | 10 ug subcutaneous control |
| Name | Type | Description |
|---|---|---|
| MKC253 Inhalation Powder | DRUG | Inhalation Powder, prandial |
| Technosphere Inhalation Powder | DRUG | Inhalation Powder, prandial |
| subcutaneous injection | DRUG | 10µg Exenatide, prandial |
Inclusion Criteria: * Non-smoking males and females between 18 and 70 years of age * Body Mass Index (BMI) of \< 32 kg/m2 * Diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, w...