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Label indication BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • BYETTA contains exenatide. Coadministration with other exenatide-containing products is not recommended. FDA label
Also known as Byetta
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...
Exenatide- Placebo- Exenatide is studied for Type 2 Diabetes Mellitus. It was evaluated in a Phase 2 trial in adolescent subjects with the condition. The study examined pharmacokinetics, pharmacodynamics, and tolerability in participants aged 10 years and older in the United States.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of Exenatide- Placebo- Exenatide. The company sponsored the clinical program evaluating the drug in adolescent subjects with Type 2 Diabetes Mellitus.
Exenatide- Placebo- Exenatide is in Phase 2 development. The single Phase 2 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved for use.
Exenatide- Placebo- Exenatide was studied in one completed Phase 2 trial, NCT00254254, titled A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus. The trial enrolled 13 participants in the United States and was randomized and controlled.
Yes, Exenatide- Placebo- Exenatide and Exenatide - Placebo - Exenatide refer to the same study drug entry. The two spellings differ only in spacing and punctuation, so searches using either name point to the same Phase 2 program in Type 2 Diabetes Mellitus.