Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, adolescents, exenatide, Amylin, Lilly
Brief summary
This study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects.
Interventions
DRUGExenatide - Exenatide - Placebo
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.
DRUGExenatide - Placebo - Exenatide
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.
DRUGPlacebo - Exenatide - Exenatide
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.
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
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 any investigational drug or has participated in any type of clinical trial within 3 months prior to screening. * Currently participates in any other interventional study. * Is currently treated with any of the following excluded medications: * Sulfonylurea chlorpropamide * Thiazolidinedione within 3 months of screening. * Αlpha glucosidase inhibitor within 3 months of screening. * Meglitinide within 3 months of screening. * Insulin within 3 months of screening. * Pramlintide within 3 months of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the pharmacokinetics of exenatide | Three day-long (8 hour) assessments over a 5-week period | 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 | Three day-long (8 hour) assessments over a 5-week period | 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. |
| Number of adverse events | Visit 2 through Visit 4 | 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 |
Countries
United States
Outcome results
None listed