Study S000052

An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to 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: NCT00111540
Study type: INTERVENTIONAL
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 456
Start: 2002-11
Primary completion: 2006-09
Lead sponsor: AstraZeneca
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:exenatide
Results posted: FALSE

Registered primary outcomes

Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit [Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)]
Change in body weight from Visit 1 to each protocol visit [Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)]
Change in fasting plasma glucose from Visit 1 to each protocol visit [Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)]
Change in lipids from Visit 1 to each protocol visit [Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)]

Linked records (5)

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
R0026474	Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Fineman MS, Diabetes, obesity & metabolism	2012	Other	PMID 22236356 DOI	cites ClinicalTrials.gov:NCT00111540; registry reference DERIVED:22236356
R0025862	Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Klonoff DC, Current medical research and opinion	2008	Randomized trial	PMID 18053320 DOI	registry reference RESULT:18053320
R0025690	The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Nelson P, Diabetes technology & therapeutics	2007	Randomized trial	PMID 17705687 DOI	cites ClinicalTrials.gov:NCT00111540; registry reference DERIVED:17705687
R0026490	Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials. Buse JB, Clinical therapeutics	2007	Randomized trial	PMID 17379054 DOI	registry reference RESULT:17379054
R0025957	Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Blonde L, Diabetes, obesity & metabolism	2006	Randomized trial	PMID 16776751 DOI	registry reference RESULT:16776751