This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
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, and non-high-density lipoprotein cholesterol)
Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol
C-reactive protein
Central obesity (waist circumference, hip circumference, waist/hip ratio)
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Research Site
Birmingham, Alabama, United States
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Columbiana, Alabama, United States
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Mobile, Alabama, United States
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Carlisle, Arkansas, United States
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Sherwood, Arkansas, United States
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Chula Vista, California, United States
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Escondido, California, United States
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Huntington Beach, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
...and 267 more locations