A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00254254 |
Recruitment Status :
Completed
First Posted : November 16, 2005
Last Update Posted : February 23, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: Exenatide - Exenatide - Placebo Drug: Exenatide - Placebo - Exenatide Drug: Placebo - Exenatide - Exenatide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | February 2007 |
Actual Study Completion Date : | February 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Sequence 1
Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL
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Drug: Exenatide - 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.
Other Name: Byetta |
Experimental: Sequence 2
Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg
|
Drug: Exenatide - 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.
Other Name: Byetta |
Experimental: Sequence 3
Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg
|
Drug: Placebo - 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.
Other Name: Byetta |
- To assess the pharmacokinetics of exenatide [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

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Ages Eligible for Study: | 10 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254254
United States, Arkansas | |
Research Site | |
Little Rock, Arkansas, United States | |
United States, California | |
Research Site | |
San Diego, California, United States | |
United States, Colorado | |
Research Site | |
Denver, Colorado, United States | |
United States, Kentucky | |
Research Site | |
Louisville, Kentucky, United States | |
United States, Texas | |
Research Site | |
San Antonio, Texas, United States |
Study Director: | Lisa Porter, MD | Amylin Pharmaceuticals, LLC. |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00254254 |
Other Study ID Numbers: |
2993-124 |
First Posted: | November 16, 2005 Key Record Dates |
Last Update Posted: | February 23, 2015 |
Last Verified: | January 2015 |
diabetes adolescents exenatide Amylin Lilly |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide |
Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |