Evaluating Atorvastatin With Omega-3 Fatty Acids in Cardiovascular Risk Reduction in Patients With Type 2 Diabetes (AFORRD)

Viatris

Status and phase: Completed; Phase 4

Conditions: Diabetes, Type 2

Treatments: Drug: Atorvastatin and Omega-3 fatty acids

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00141232

A2581114

Details and patient eligibility

About

The AFORRD trial is asking three important questions:

What proportion of people with Type 2 Diabetes are likely to be treated satisfactorily with a fixed dose of a statin that lowers blood cholesterol levels to help reduce the risk of heart disease? To what extent do omega-3 fatty acids lower blood triglyceride levels when given with or without a statin? Are there simple techniques that can help people to take their tablets on a regular basis?

Enrollment: 810 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• They have a diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to entry.
• Are not known to have had a cardiovascular event

Exclusion criteria

• They are taking prescribed lipid lowering therapy
• Have triglycerides > or = 8.0 mmol/L

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind