Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Exenatide - Placebo - Exenatide
Exenatide- Placebo- Exenatide · 1 trial · 1 indication
To assess pharmacokinetics of exenatide by measuring peak plasma time, time to peak concentration, terminal elimination half-life, apparent elimination time constant, apparent clearance, apparent volume of distribution, and area under concentration curve.
To assess the pharmacodynamics of exenatide by measuring plasma glucose, serum insulin, and plasma glucagon: absolute and incremental area under the curve 0-3 hours), absolute and incremental area under the curve (0-6 hours), areas under the concentration-time curve (0-6 h), peak plasma contration, and time to peak concentration.
Adverse events will be assessed at all visits after the Screening Visit \[Visit 2 (first time subject is dosed) through Visit 4 (study termination)\]. All events assessed with special attention to changes in vital signs, ECGs, and laboratory values
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL |
| Sequence 2 | EXPERIMENTAL | Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg |
| Sequence 3 | EXPERIMENTAL | Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg |
| Name | Type | Description |
|---|---|---|
| Exenatide - Exenatide - Placebo | DRUG | Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose, followed by placebo 0.02 mL, single dose. All are subcutaneous injections. |
| Exenatide - Placebo - Exenatide | DRUG | Exenatide 2.5 mcg, single dose, followed by placebo 0.02 mL, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections. |
| Placebo - Exenatide - Exenatide | DRUG | Placebo 0.02 mL, single dose, followed by Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections. |
Inclusion Criteria: * Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 3 months. * Has HbA1c 6.0% to 11.0%, inclusive, at screening. * Has a body weight of \>= 50 kg at screening. Exclusion Criteria: * Received an...