Type 2 Diabetes Clinical Trial
Official title:
A Placebo-Controlled, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Lapaquistat Acetate 100 mg in Subjects With Type 2 Diabetes Currently Treated With Lipid-Lowering Therapy
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with established lipid-lowering therapy in subjects with type 2 diabetes mellitus.
Diabetes mellitus is a recognized cause of secondary dyslipidemia, and is also independently
considered to be a major cardiovascular risk factor requiring aggressive lipid-lowering
treatment. Type 2 diabetes accounts for 85% to 90% of diabetes worldwide. It affects about
2% of the Caucasian population in most Westernized countries, and the prevalence rises with
age to 10% in those over 70 years of age. Five percent or more of young- and middle-aged
adults in some Asian or Afro-Caribbean groups in the United Kingdom have this condition.
Approximately 12 million Americans have type 2 diabetes, and an estimated 20 million more
have some degree of glucose intolerance. The greatest cause of mortality in type 2 diabetes
is atherosclerotic vascular disease and its sequelae between 75% and 80% of adult subjects
with diabetes die of macrovascular complications.
Lapaquistat acetate is a squalene synthase inhibitor currently under development at Takeda
for the treatment of dyslipidemia. This study will evaluate the efficacy and safety of
lapaquistat acetate co-administered with an established lipid-lowering therapy including
atorvastatin, simvastatin, rosuvastatin, or fenofibrate in subjects with type 2 diabetes
mellitus.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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