Study S001020

A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00097500
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 69
Start: 2004-09
Primary completion: 2009-12
Lead sponsor: AstraZeneca
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:exenatide; DRUG:Insulin glargine; DRUG:Metformin
Results posted: TRUE

Registered primary outcomes

Beta-cell Function After 52 Weeks of Therapy [Baseline (week -2) and 52 weeks]

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
R0010237	Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Natale P, The Cochrane database of systematic reviews	2025	Systematic review	PMID 39963952 DOI	cites ClinicalTrials.gov:NCT00097500; registry reference DERIVED:39963952
R0021224	Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial. Muskiet MHA, Diabetes research and clinical practice	2019	Randomized trial	PMID 31078666 DOI	cites ClinicalTrials.gov:NCT00097500; registry reference DERIVED:31078666
R0027787	Effects of exenatide on measures of β-cell function after 3 years in metformin-treated patients with type 2 diabetes. Bunck MC, Diabetes care	2011	Randomized trial	PMID 21868779 DOI	cites ClinicalTrials.gov:NCT00097500; registry reference DERIVED:21868779
R0027314	One-year treatment with exenatide vs. insulin glargine: effects on postprandial glycemia, lipid profiles, and oxidative stress. Bunck MC, Atherosclerosis	2010	Randomized trial	PMID 20494360 DOI	cites ClinicalTrials.gov:NCT00097500; registry reference DERIVED:20494360
R0027264	One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Bunck MC, Diabetes care	2009	Randomized trial	PMID 19196887 DOI	registry reference RESULT:19196887