HARMONY Outcomes Trial
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
GlaxoSmithKline Research & Development Limited
Duration of Study in the UK
4 years, 5 months, 21 days
This is a GSK sponsored trial in type 2 diabetic subjects with a previous history of cardiovascular disease and who are failing to control their blood sugar levels with their current treatment.
Subjects should be at least 40 years old and have established cardiovascular disease and a HbA1c (a measure of longer term blood sugar level control over the past 8-12 weeks) above 7%. If subjects meet all eligibility criteria and wish to participate in the study, they will be randomised to one of the following treatment groups in a 1:1 ratio:
•Albiglutide added on to standard of care.
•Placebo added on to standard of care.
A total of 9400 subjects with type 2 diabetes will be studied. This study is designed with minimal intervention above normal clinic care of subjects. Contact with subjects will be every 4 months after randomisation. Visit assessments include: blood tests, assessment of kidney and liver functioning and a physical exam. Subjects will remain in the study until approx 611 major adverse cardiovascular events (MACE) have occurred. This is estimated to be between 3-5 years. MACE events include cardiovascular death, myocardial infarction (heart attack), stroke and hospitalization for unstable angina (chest pain/ tightness/breathlessness at rest, caused by circulatory problems).
The main objective is to determine whether albiglutide is non-inferior with respect to MACE when added to standard of care versus standard of care alone.
Additional objectives are: evaluation of albiglutide on cardiovascular outcomes; the effects of albiglutide on metabolic management of type 2 diabetes; the safety of albiglutide. Patient reported outcomes to evaluate patient experiences of diabetes treatment will also be captured.
A subset of sites will also take part in the electronic health record (EHR) ancillary study. Ancillary study objectives include:
•Assess the barriers to using an EHR-generated list of patients to facilitate trial enrolment
•Evaluate the fitness of EHR data for use in populating the baseline characteristics in the electronic CRF.
•Explore the use of EHR data to find events of interest during trial follow-up.
South Central - Oxford A Research Ethics Committee
Date of REC Opinion
17 Apr 2015
Further Information Favourable Opinion