Study S000402

A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT00637273
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 514
Start: 2008-01
Primary completion: 2009-02
Lead sponsor: AstraZeneca
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:exenatide once weekly; DRUG:sitagliptin; DRUG:pioglitazone; DRUG:placebo tablet; DRUG:placebo once weekly
Results posted: TRUE

Registered primary outcomes

Change in HbA1c From Baseline to Week 26 [Day 1, Week 26]

Linked records (7)

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
R0013562	Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Guja C, Diabetes therapy : research, treatment and education of diabetes and related disorders	2020	Other trial	PMID 32306296 DOI	cites ClinicalTrials.gov:NCT00637273; registry reference DERIVED:32306296
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:NCT00637273; registry reference DERIVED:23748506
R0024240	Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Meloni AR, Cardiovascular diabetology	2013	Randomized trial	PMID 23522121 DOI	cites ClinicalTrials.gov:NCT00637273; registry reference DERIVED:23522121
R0025752	Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data. Malloy J, Postgraduate medicine	2013	Randomized trial	PMID 23748507 DOI	cites ClinicalTrials.gov:NCT00637273; registry reference DERIVED:23748507
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:NCT00637273; registry reference DERIVED:22236356
R0024641	DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide. Wysham C, Diabetic medicine : a journal of the British Diabetic Association	2011	Randomized trial	PMID 21434995 DOI	cites ClinicalTrials.gov:NCT00637273; registry reference DERIVED:21434995
R0020417	Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Bergenstal RM, Lancet (London, England)	2010	Randomized trial	PMID 20580422 DOI	cites ClinicalTrials.gov:NCT00637273; registry reference DERIVED:20580422