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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide

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.