Study S001074

A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02465515
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 9463
Start: 2015-07-01
Primary completion: 2018-02-20
Lead sponsor: GlaxoSmithKline
Conditions: Diabetes Mellitus
Interventions: BIOLOGICAL:Albiglutide 30 mg; BIOLOGICAL:Albiglutide 50 mg; BIOLOGICAL:Albiglutide matching placebo
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2014-001824-32; NIH:2014

Registered primary outcomes

Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period [Median of 1.65 person years for CV follow-up time period]

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
R0003552	Type 2 diabetes risk alleles in peptidyl-glycine alpha-amidating monooxygenase influence GLP-1 levels and response to GLP-1 receptor agonists. Umapathysivam MM, Genome medicine	2026	Other trial	PMID 41906117 DOI	cites ClinicalTrials.gov:NCT02465515; registry reference DERIVED:41906117
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:NCT02465515; registry reference DERIVED:39963952
R0003688	Effect of albiglutide on cardiovascular outcomes in older adults: A post hoc analysis of a randomized controlled trial. Gilbert MP, Diabetes, obesity & metabolism	2024	Randomized trial	PMID 38317618 DOI	cites ClinicalTrials.gov:NCT02465515; registry reference DERIVED:38317618
R0026465	The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study. O'Brien EC, Trials	2021	Other trial	PMID 34281607 DOI	cites ClinicalTrials.gov:NCT02465515; registry reference DERIVED:34281607
R0007117	Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Wittbrodt ET, The American journal of managed care	2018	Nonrandomized study	PMID 29693361	cites ClinicalTrials.gov:NCT02465515; registry reference DERIVED:29693361
R0010777	Harmony Outcomes: A randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus-Rationale, design, and baseline characteristics. Green JB, American heart journal	2018	Protocol	PMID 30015066 DOI	cites ClinicalTrials.gov:NCT02465515; registry reference DERIVED:30015066
R0012223	Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Hernandez AF, Lancet (London, England)	2018	Randomized trial	PMID 30291013 DOI	cites ClinicalTrials.gov:NCT02465515; registry reference DERIVED:30291013