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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254254
• Other study ID #: 2993-124
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2005
• Last updated: February 19, 2015
• Start date: February 2006
• Est. completion date: February 2007

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 16 Years

Eligibility

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.

• ?lpha 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Research Site	Denver	Colorado
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Louisville	Kentucky
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	No