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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01021527 | A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED) | PHASE1 | COMPLETED | 12 | — | — | Feb 1, 2008 | Apr 1, 2008 | Apr 28, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | A-B-C-C |
| Treatment Sequence 2 | EXPERIMENTAL | B-C-A-C |
| Treatment Sequence 3 | EXPERIMENTAL | C-A-B-C |
| Treatment Sequence 4 | EXPERIMENTAL | A-C-B-C |
| Treatment Sequence 5 | EXPERIMENTAL | B-A-C-C |
| Treatment Sequence 6 | EXPERIMENTAL | C-B-A-C |
| Name | Type | Description |
|---|---|---|
| Comparator: Treatment A | OTHER | No Treatment |
| Comparator: Treatment B | DRUG | single dose administration of exenatide 5ug by subcutaneous injection |
| Comparator: Treatment C | DRUG | single dose administration of exenatide 10ug by subcutaneous injection |
| Comparator: graded glucose infusion | PROCEDURE | A stepwise graded infusion of glucose (20% dextrose \[D20\]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods. |
Inclusion Criteria: * Subject is in good health * Subject is a non-smoker Exclusion Criteria: * Subject has irritable bowel disease * Subject has a history of cancer * Subject has a history of hypertension requiring treatment * Subject is unable to refrain from the use of any prescription or non-...