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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00782418 | A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED) | PHASE1 | COMPLETED | 27 | — | — | Sep 1, 2008 | Mar 1, 2009 | Dec 21, 2016 | - | — |
Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate. Insulin Secretion Rate (ISR)/ Blood Glucose (BG)
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | exenatide 5mcg |
| 2 | ACTIVE_COMPARATOR | exenatide 1.5mcg |
| 3 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Comparator: exenatide | DRUG | exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI. |
| Comparator: Placebo | DRUG | 5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI. |
Inclusion Criteria: * Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening * Subject is judged to be in good health * Subject has been a nonsmoker for at least 3 months * Subject is willing to avoid strenuous physical activity for the duration of the study Exclusion C...