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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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 Design

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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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Sequence 1; Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL	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

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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.
3. 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

Eligibility Criteria

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Ages Eligible for Study:	10 Years to 16 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

AstraZeneca

Eli Lilly and Company

Investigators

Study Director:	Lisa Porter, MD	Amylin Pharmaceuticals, LLC.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Malloy J, Capparelli E, Gottschalk M, Guan X, Kothare P, Fineman M. Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study. Clin Ther. 2009 Apr;31(4):806-15. doi: 10.1016/j.clinthera.2009.04.005.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00254254 History of Changes
Other Study ID Numbers:	2993-124
First Posted:	November 16, 2005
Last Update Posted:	February 23, 2015
Last Verified:	January 2015

Keywords provided by AstraZeneca:

diabetes; adolescents; exenatide; Amylin; Lilly

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Exenatide	Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists