Phase 4
Completed N=9,463
Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02465515 ↗Enrolled (actual)
9,463
Serious AEs
20.7%
Results posted
Mar 2019
Primary outcomePrimary: Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period — 5.87; 4.57 Events per 100 person years — p=<0.0001
◆ Published Evidence
Highly cited
1,771citations · ~221 / year
Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial.
Summary
Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.
Linked Publications (5)
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Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial.
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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.
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The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study.
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Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
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Effect of albiglutide on cardiovascular outcomes in older adults: A post hoc analysis of a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period |
5.87; 4.57 | <0.0001 sig |
| SECONDARY Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina |
6.45; 5.06 | <0.001 sig |
| SECONDARY Time to Adjudicated CV Death |
1.72; 1.61 | 0.578 |
| SECONDARY Time to First Occurrence of Adjudicated MI |
3.26; 2.43 | 0.003 sig |
| SECONDARY Time to First Occurrence of Adjudicated Stroke |
1.45; 1.25 | 0.300 |
| SECONDARY Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF) |
2.92; 2.49 | 0.113 |
| SECONDARY Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start |
8.58; 3.56 | <0.001 sig |
| SECONDARY Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start |
5.09; 3.59 | 0.043 sig |
| SECONDARY Percentage of Participants Achieving Composite Metabolic Endpoint |
15.4; 32.2; 16.5; 28.7; 17.8; 28.6 | <0.001 sig |
| SECONDARY Time to First Occurrence of a Clinically Important Microvascular Event |
0.69; 0.46 | 0.055 |
| SECONDARY Change From Baseline in HbA1c |
-0.28; -0.92; -0.31; -0.83 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
-0.36; -1.02; -0.53; -1.36 | <0.001 sig |
| SECONDARY Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score |
4.53; 6.92; 4.80; 7.13 | <0.001 sig |
| SECONDARY Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score |
1.36; 2.83; 1.87; 2.39 | <0.001 sig |
| SECONDARY Time to Death |
2.56; 2.44 | 0.644 |
| SECONDARY Number of Participants With Non-fatal Serious Adverse Events (SAEs) |
974; 891 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD) |
334; 427 | — |
| SECONDARY Number of Participants With AEs of Special Interest |
0; 0; 5; 9; 5; 6 | — |
| SECONDARY Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula |
1.22; 0.10; -0.90; -1.33 | 0.003 sig |
| SECONDARY Change From Baseline in Blood Pressure |
-0.5; -1.0; -0.5; -0.9; -0.9; -1.2 | — |
| SECONDARY Change From Baseline in Heart Rate |
0.2; 1.6; 0.3; 1.6; 0.6; 1.7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02465515) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.