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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT00254254 (opens ClinicalTrials.gov in a new tab)Other id2993-124
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
13 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Single masking
Countries
1 country

United States

Start
Feb 2006
Primary completion
Feb 2007
Completion
Feb 2007
First posted
16 Nov 2005 (estimated)
Last update posted
23 Feb 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 2

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

    NCT00254254

    Feb 2006 to Feb 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Exenatide - Exenatide - PlaceboDrug
  • Exenatide - Placebo - ExenatideDrug
  • Placebo - Exenatide - ExenatideDrug

Arms3

  • Experimental

    Sequence 1

    Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL

  • Experimental

    Sequence 2

    Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg

  • Experimental

    Sequence 3

    Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. To assess the pharmacokinetics of exenatide

    Time frame · Three day-long (8 hour) assessments over a 5-week period

    Registry description

    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.

  2. To assess the pharmacodynamics of exenatide

    Time frame · Three day-long (8 hour) assessments over a 5-week period

    Registry description

    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.

  3. Number of adverse events

    Time frame · Visit 2 through Visit 4

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2009

11 results

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.

Malloy et al. 2009Clinical therapeuticscited by 29

PMID 19446153DOI 10.1016/j.clinthera.2009.04.005PUB-19446153

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 10 Years up to 16 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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