CompletedPhase 4Results posted

Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus

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

Lead sponsor

GlaxoSmithKline

Asset

Albiglutide

Subcutaneous · GLP-1 agonist

Listed sites

607

Recruiting sites

Actual enrollment

9,463

Study population

Cardiovascular disease, Type 2 diabetes

Eligibility highlights

•Established CVD•HbA1c ≥7%

Primary endpoint

•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02465515

Org study ID116174

Secondary ID2014-001824-32

Timeline

Milestones

Study first posted2015-06-08estimated

Study start2015-07-01actual

Primary completion2018-02-20actual

Study completion2018-03-14actual

Last update posted2019-03-06actual

Results first posted2019-03-06actual

Assets

Investigational agents

Albiglutide

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.

•Diagnosis of type 2 diabetes.

•Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.

•HbA1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).

•Able and willing to provide informed consent.

Exclusion criteria

•Severely reduced kidney function: eGFR <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.

•Use of a GLP-1 receptor agonist at Screening.

•Severe gastroparesis

•History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.

•Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.

•Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.

•Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.

•Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.

•Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.

•Any other reason the investigator deems the subject to be unsuitable for the study.

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes

Glycemic / diabetes

Safety / tolerability / PK

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

Renal / kidney

Other clinical outcomes

Cardiovascular outcomes

7 endpoints

Primary/protocol endpoint

Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period

Time frame:Median of 1.65 person years for CV follow-up time period

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	5.87	5.33 - 6.45
Albiglutide	4.57	4.10 - 5.08

Hazard ratio (hr)0.7895% CI0.68 - 0.90p<0.0001Wald test

p<0.001Wald test

Secondary/protocol endpoint

Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina

Time frame:Median of 1.65 person years for CV follow-up time period

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Coronary revascularization, Unstable angina hospitalization

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	6.45	5.88 - 7.06
Albiglutide	5.06	4.56 - 5.60

Hazard ratio (hr)0.7895% CI0.69 - 0.90p<0.001Wald statistic

Secondary/protocol endpoint

Time to Adjudicated CV Death

Time frame:Median of 1.65 person years for the CV follow-up time period

Cardiovascular death

time to event, event

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	1.72	1.44 - 2.04
Albiglutide	1.61	1.33 - 1.92

Hazard ratio (hr)0.9395% CI0.73 - 1.19p0.578Wald statistic

Secondary/protocol endpoint

Time to First Occurrence of Adjudicated MI

Time frame:Median of 1.65 person years for CV follow-up time period

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	3.26	2.86 - 3.70
Albiglutide	2.43	2.09 - 2.81

Hazard ratio (hr)0.7595% CI0.61 - 0.90p0.003Wald statistic

Secondary/protocol endpoint

Time to First Occurrence of Adjudicated Stroke

Time frame:Median of 1.65 person years for CV follow-up time period

Stroke (any)

time to event, event

SNOMED 230690007

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	1.45	1.19 - 1.74
Albiglutide	1.25	1.01 - 1.53

Hazard ratio (hr)0.8695% CI0.66 - 1.14p0.300Wald statistic

Secondary/protocol endpoint

Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF)

Time frame:Median of 1.65 person years for CV follow-up time period

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Heart-failure hospitalization

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	2.92	2.55 - 3.34
Albiglutide	2.49	2.15 - 2.88

Hazard ratio (hr)0.8595% CI0.70 - 1.04p0.113Wald statistic

Secondary/protocol endpoint

Time to Death

Time frame:Median of 1.73 years for the Vital Status follow-up time period

All-cause death

time to event, event

SNOMED 419620001

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	2.56	2.22 - 2.93
Albiglutide	2.44	2.11 - 2.81

Hazard ratio (hr)0.9595% CI0.79 - 1.16p0.644Wald test

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline and Months 8 and 16

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · Kilograms	95% CI
PlaceboMonth 8, n=4217, 4286	-0.36	-
Month 16, n=3068, 3173	-0.53	-
AlbiglutideMonth 8, n=4217, 4286	-1.02	-
Month 16, n=3068, 3173	-1.36	-

Mean difference (net)-0.6695% CI-0.83 - -0.49p<0.001t-test, 2 sided

Mean difference (net)-0.8395% CI-1.06 - -0.60p<0.001t-test, 2 sided

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start

Time frame:Up to 2.7 years

time to event, event

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	8.58	7.56 - 9.70
Albiglutide	3.56	2.92 - 4.31

Hazard ratio (hr)0.4295% CI0.33 - 0.53p<0.001Wald test

Secondary/protocol endpoint

Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start

Time frame:Up to 2.7 years

time to event, event

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	5.09	4.06 - 6.31
Albiglutide	3.59	2.73 - 4.63

Hazard ratio (hr)0.7195% CI0.51 - 0.99p0.043Wald test

Secondary/protocol endpoint

Percentage of Participants Achieving Composite Metabolic Endpoint

Time frame:Months 8, 16, 24 and final assessment (up to 2.7 years)

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Number · Percentage of participants	95% CI
PlaceboMonth 8, n=4127, 4195	15.4	-
Month 16, n=3026, 3118	16.5	-
Month 24, n=1119, 1173	17.8	-
Final assessment, n=4401, 4455	15.1	-
AlbiglutideMonth 8, n=4127, 4195	32.2	-
Month 16, n=3026, 3118	28.7	-
Month 24, n=1119, 1173	28.6	-
Final assessment, n=4401, 4455	26.0	-

p<0.001Mantel Haenszel

Secondary/protocol endpoint

Change From Baseline in HbA1c

Time frame:Baseline and Months 8 and 16

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · % HbA1c	95% CI
PlaceboMonth 8, n=4211, 4289	-0.28	-
Month 16, n=3066, 3163	-0.31	-
AlbiglutideMonth 8, n=4211, 4289	-0.92	-
Month 16, n=3066, 3163	-0.83	-

Mean difference (net)-0.6395% CI-0.69 - -0.58p<0.001t-test, 2 sided

Mean difference (net)-0.5295% CI-0.58 - -0.45p<0.001t-test, 2 sided

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula

Time frame:Baseline and Months 8 and 16

eGFR, change

change from baseline, improvement

Posted result

Group	Least-squares mean · Milliliter/minute/1.73 meter square	95% CI
PlaceboMonth 8; n=3977,4008	1.22	-
Month 16; n=2354,2496	-0.90	-
AlbiglutideMonth 8; n=3977,4008	0.10	-
Month 16; n=2354,2496	-1.33	-

Mean difference (net)-1.1195% CI-1.84 - -0.39p0.003t-test, 2 sided

Mean difference (net)-0.4395% CI-1.26 - 0.41p0.315t-test, 2 sided

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Blood Pressure

Time frame:Baseline and Months 8,16,24 and end of study (up to 2.7 years)

change from baseline, improvement

Posted result

Group	Mean · Millimeter of mercury	95% CI
PlaceboSBP, Month 8; n=4241, 4319	-0.5	-
SBP, Month 16; n=3082, 3187	-0.5	-
SBP, Month 24; n=1133, 1198	-0.9	-
SBP, End of study; n=3897, 4015	0.0	-
DBP, Month 8; n=4241, 4319	-0.5	-
DBP, Month 16; n=3082, 3187	-0.9	-
DBP, Month 24; n=1133, 1198	-1.1	-
DBP, End of study; n=3897, 4015	-0.7	-
AlbiglutideSBP, Month 8; n=4241, 4319	-1.0	-
SBP, Month 16; n=3082, 3187	-0.9	-
SBP, Month 24; n=1133, 1198	-1.2	-
SBP, End of study; n=3897, 4015	-0.4	-
DBP, Month 8; n=4241, 4319	-0.4	-
DBP, Month 16; n=3082, 3187	-0.5	-
DBP, Month 24; n=1133, 1198	-1.0	-
DBP, End of study; n=3897, 4015	-0.6	-

Secondary/protocol endpoint

Change From Baseline in Heart Rate

Time frame:Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)

Heart rate, change

change from baseline, improvement

Posted result

Group	Mean · Beats per minute	95% CI
PlaceboMonth 8; n=4239, 4312	0.2	-
Month 16; n=3078, 3181	0.3	-
Month 24; n=1131, 1195	0.6	-
End of study; n=3892, 4005	0.8	-
AlbiglutideMonth 8; n=4239, 4312	1.6	-
Month 16; n=3078, 3181	1.6	-
Month 24; n=1131, 1195	1.7	-
End of study; n=3892, 4005	1.8	-

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score

Time frame:Baseline and Months 8 and 16

change from baseline, improvement

Posted result

Group	Least-squares mean · Scores on a scale	95% CI
PlaceboMonth 8, n=3013, 3041	4.53	-
Month 16, n=1738, 1840	4.80	-
AlbiglutideMonth 8, n=3013, 3041	6.92	-
Month 16, n=1738, 1840	7.13	-

Mean difference (net)2.3995% CI1.85 - 2.93p<0.001t-test, 2 sided

Mean difference (net)2.3395% CI1.66 - 3.01p<0.001t-test, 2 sided

Secondary/protocol endpoint

Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score

Time frame:Baseline and Months 8 and 16

EQ-5D VAS

change from baseline, improvement

Posted result

Group	Least-squares mean · Scores on a scale	95% CI
PlaceboMonth 8, n=3982, 4014	1.36	-
Month 16, n=2347, 2481	1.87	-
AlbiglutideMonth 8, n=3982, 4014	2.83	-
Month 16, n=2347, 2481	2.39	-

Mean difference (net)1.4795% CI0.87 - 2.07p<0.001t-test, 2 sided

Mean difference (net)0.5295% CI-0.26 - 1.31p0.192t-test, 2 sided

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of Participants With Non-fatal Serious Adverse Events (SAEs)

Time frame:Up to 2.7 years

Serious AEs (any)

event count, event

Posted result

Group	Participants	95% CI
Placebo	974	-
Albiglutide	891	-

Secondary/protocol endpoint

Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD)

Time frame:Up to 2.7 years

Discontinuation due to AE

event count, event

Posted result

Group	Participants	95% CI
Placebo	334	-
Albiglutide	427	-

Secondary/protocol endpoint

Number of Participants With AEs of Special Interest

Time frame:Up to 2.7 years

event count, event

Posted result

Group	Participants	95% CI
PlaceboThyroid cancer diagnosis	0	-
Hematologic malignancy	5	-
Pancreatic cancer	5	-
Investigational product injection site reaction	29	-
Hypersensitivity	48	-
Severe hypoglycemic events	55	-
Hepatic events	74	-
Hepatic enzyme elevations (including GGT)	34	-
Serious GI Events	87	-
Appendicitis	8	-
Atrial fibrillation/atrial flutter	131	-
Pneumonia	138	-
Renal impairment	319	-
Diabetic retinopathy	89	-
Investigator-reported pancreatitis	13	-
Pancreatitis positively adjudicated by PAC	7	-
AlbiglutideThyroid cancer diagnosis	0	-
Hematologic malignancy	9	-
Pancreatic cancer	6	-
Investigational product injection site reaction	86	-
Hypersensitivity	45	-
Severe hypoglycemic events	31	-
Hepatic events	98	-
Hepatic enzyme elevations (including GGT)	51	-
Serious GI Events	92	-
Appendicitis	3	-
Atrial fibrillation/atrial flutter	108	-
Pneumonia	131	-
Renal impairment	279	-
Diabetic retinopathy	78	-
Investigator-reported pancreatitis	14	-
Pancreatitis positively adjudicated by PAC	10	-

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

Time to First Occurrence of a Clinically Important Microvascular Event

Time frame:Up to 2.7 years

time to event, event

componentsKidney-replacement therapy, End-stage renal disease

Posted result

Group	Number · Events per 100 person years	95% CI
Placebo	0.69	0.52 - 0.90
Albiglutide	0.46	0.32 - 0.63

Hazard ratio (hr)0.6695% CI0.43 - 1.01p0.055Wald test

Publications (7)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Type 2 diabetes risk alleles in peptidyl-glycine alpha-amidating monooxygenase influence GLP-1 levels and response to GLP-1 receptor agonists.
Genome medicine2026 Mar 29PMID41906117doi:10.1186/s13073-026-01630-0via pubmed nct search
Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Effect of albiglutide on cardiovascular outcomes in older adults: A post hoc analysis of a randomized controlled trial.
Diabetes, obesity & metabolism2024 May (month)PMID38317618doi:10.1111/dom.15479via clinicaltrials gov reference derived + pubmed nct search
The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study.
Trials2021 Jul 19PMID34281607doi:10.1186/s13063-021-05397-0via clinicaltrials gov reference derived + pubmed nct search
Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial.
Lancet (London, England)2018 Oct 27PMID30291013doi:10.1016/S0140-6736(18)32261-Xvia clinicaltrials gov reference derived + pubmed nct search
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.
American heart journal2018 Sep (month)PMID30015066doi:10.1016/j.ahj.2018.03.030via clinicaltrials gov reference derived + pubmed nct search
Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.
The American journal of managed care2018 Apr (month)PMID29693361via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.