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 (Harmony Outcomes Trial, GLP116174)

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 (Harmony Outcomes Trial, GLP116174) - GLP116174, Harmony Outcomes Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45225

Enrollment

120

Registered

2017-08-01

Start date

2015-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes type 2

Interventions

Treatment with albiglutide or placebo.

albiglutide

cardiovascular disease

diabetes

Harmony

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Men and women at least 40 years old with a diagnosis of type 2 diabetes. * Established cardiovascular disease. See protocol page 23-24 for details. * HbA1c >7.0% (at most 6 months prior to randomization). * Females of childbearing potential: adequate method of contraception. See protocol page 24 for details.

Exclusion criteria

Exclusion criteria: * eGFR calculated using MDRD formula

Design outcomes

Primary

Measure	Time frame
Time to MACE.	—

Secondary

Measure	Time frame
Time urgent revascularization for unstable angina. Time to CV death, myocardial infarction or stroke. CV death or hospitalization due to heart failure. Adverse events.	—

Countries

Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Italy, Korea (the Republic of), Mexico, Netherlands, Norway, Peru, Philippines, Poland, Puerto Rico, Russian Federation, South Africa, Spain, Sweden, Taiwan (Province of China), Thailand, Ukraine, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)