Type 2 Diabetes Mellitus, Hypercholesterolemia
Conditions
Brief summary
The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.
Interventions
DRUGDuration of Treatment: 4 wk placebo run in then 6 wk active
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs.
Exclusion criteria
* Type 1 Diabetes Mellitus * Type 2 Diabetes Mellitus that is poorly controlled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction in LDL-C from baseline after 6 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment | — |
Outcome results
None listed