Study S000452

Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.

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 Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT00658021
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 122
Start: 2008-05-30
Primary completion: 2019-04-18
Lead sponsor: AstraZeneca
Conditions: Type 2 Diabetes
Interventions: DRUG:Placebo; DRUG:Exenatide
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:H8O-MC-GWBQ

Registered primary outcomes

Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28 [Baseline (Day 1) and Week 28]
Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period [From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.]

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
R0051939	Expanding Treatment Options for Youth With Type 2 Diabetes: Current Problems and Proposed Solutions William V. Tamborlane, Diabetes Care	2016	Other	PMID 26908928 DOI	cites ClinicalTrials.gov:NCT00658021