Clinical trial NCT00254254: A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Exenatide in Adolescent Subjects With Type 2 Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
adolescents
exenatide
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2005-11-16
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: To assess the pharmacokinetics of exenatide
timeFrame: Three day-long (8 hour) assessments over a 5-week period
measure: To assess the pharmacodynamics of exenatide
timeFrame: Three day-long (8 hour) assessments over a 5-week period
measure: Number of adverse events
timeFrame: Visit 2 through Visit 4
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: San Diego
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Lisa Porter, MD
role: STUDY_DIRECTOR
References:
citation: 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.