Diabetes, Type 2
Conditions
Brief summary
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?
Interventions
DRUGAtorvastatin and Omega-3 fatty acids
Sponsors
Churchill Hospital
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prim objective (16 wks) for atorvastatin: Proportion of pats. who achieve measured | — |
| LDL levels <2.6 mmol/L (<100 mg/dl) Prim object (16 wks) for Omega-3 fatty acid: | — |
| Prop of pats. who achieve measured triglycerides <1.5 mmol/L (<200 mg/dl) | — |
Secondary
| Measure | Time frame |
|---|---|
| Prop of pats who achieve LDL levels <2.6 mmol/L (<100 mg/dl) at 52 weeks, taking into account whether the patient received additional atorvastatin therapy or placebo at week 16. | — |
| Prop of pats who achieve triglycerides <1.5 mmol/L (<200 mg/dl) at 52 weeks. | — |
Countries
United Kingdom
Outcome results
None listed