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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Exenatide - Placebo - Exenatide; Drug: Exenatide - Exenatide - Placebo; Drug: Placebo - Exenatide - Exenatide

• Registration Number: NCT00254254
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-14
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-16
• Study Start: 2006-02
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Exenatide - Placebo - Exenatide	Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg
Sequence 1	Exenatide - Exenatide - Placebo	Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL
Sequence 3	Placebo - Exenatide - Exenatide	Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg

Primary Outcome Measures

Name	Time	Method
To assess the pharmacodynamics of exenatide	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	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
To assess the pharmacokinetics of exenatide	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States