Study S001308

A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00877890
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: NONE
Status: COMPLETED
Enrollment: 254
Start: 2009-03
Primary completion: 2009-10
Lead sponsor: AstraZeneca
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:exenatide once weekly; DRUG:exenatide twice daily
Results posted: TRUE

Registered primary outcomes

Change in HbA1c From Baseline to Week 24 [Day 1, Week 24]

Linked records (4)

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
R0025248	Onset of Glycemic and Weight Outcomes in Patients Initiating Exenatide Once Weekly: The Relationship of Exenatide Exposure with Efficacy over the First 24 Weeks of Treatment. Blevins T, Diabetes therapy : research, treatment and education of diabetes and related disorders	2016	Randomized trial	PMID 27146799 DOI	cites ClinicalTrials.gov:NCT00877890; registry reference DERIVED:27146799
R0019490	Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Grimm M, Postgraduate medicine	2013	Randomized trial	PMID 23748506 DOI	cites ClinicalTrials.gov:NCT00877890; registry reference DERIVED:23748506
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:NCT00877890; registry reference DERIVED:22236356
R0027649	DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. Blevins T, The Journal of clinical endocrinology and metabolism	2011	Randomized trial	PMID 21307137 DOI	registry reference RESULT:21307137