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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Exenatide - Placebo - Exenatide; Drug: Placebo - Exenatide - Exenatide; Drug: Exenatide - Exenatide - Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254254

2993-124

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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13 participants in 3 patient groups

Sequence 1

Experimental group

Description:

Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL

Treatment:

Drug: Exenatide - Exenatide - Placebo

Sequence 2

Experimental group

Description:

Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg

Treatment:

Drug: Exenatide - Placebo - Exenatide

Sequence 3

Experimental group

Description:

Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg

Treatment:

Drug: Placebo - Exenatide - Exenatide