This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,100
(0.5 or 1 mg)
(15, 30 or 45 mg)
Adverse events
Laboratory variables
Physical examination
Cardiac evaluation
Hypoglycemic events
Electrocardiogram
Vital signs (blood pressure and pulse)
Body weight
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C
C-reactive protein (CRP)
Central obesity (waist circumference, hip circumference, waist/hip ratio)
Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
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Research Site
Birmingham, Alabama, United States
Research Site
Columbiana, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Chandler, Arizona, United States
Research Site
Mesa, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Sierra Vista, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Jonesboro, Arkansas, United States
Research Site
Little Rock, Arkansas, United States
...and 161 more locations