A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Single-Blind, Dose-Rising, Placebo-Controlled, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Exenatide - Exenatide - Placebo
* Drug: Exenatide - Placebo - Exenatide
* Drug: Placebo - Exenatide - Exenatide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL | Drug: Exenatide - Exenatide - Placebo<br>* 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.<br>* Other names: Byetta;|
| Experimental: Sequence 2<br>Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg | Drug: Exenatide - Placebo - Exenatide<br>* 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.<br>* Other names: Byetta;|
| Experimental: Sequence 3<br>Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg | Drug: Placebo - Exenatide - Exenatide<br>* 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.<br>* Other names: Byetta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics of exenatide | 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. | Three day-long (8 hour) assessments over a 5-week period | 
| To assess the pharmacodynamics of exenatide | 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. | Three day-long (8 hour) assessments over a 5-week period | 
| Number of adverse events | 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 | Visit 2 through Visit 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, adolescents, exenatide, Amylin, Lilly