Study S002220

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT00254254
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: SINGLE
Status: COMPLETED
Enrollment: 13
Start: 2006-02
Primary completion: 2007-02
Lead sponsor: AstraZeneca
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:Exenatide - Exenatide - Placebo; DRUG:Exenatide - Placebo - Exenatide; DRUG:Placebo - Exenatide - Exenatide
Results posted: FALSE

Registered primary outcomes

To assess the pharmacokinetics of exenatide [Three day-long (8 hour) assessments over a 5-week period]
To assess the pharmacodynamics of exenatide [Three day-long (8 hour) assessments over a 5-week period]
Number of adverse events [Visit 2 through Visit 4]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0027086	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 J, Clinical therapeutics	2009	Randomized trial	PMID 19446153 DOI	cites ClinicalTrials.gov:NCT00254254; registry reference DERIVED:19446153