GLAD ( Glucose and Lipid Assessment in Diabetes ), a phase II dose-ranging study, assessed the effects of Tesaglitazar ( Galida ) on glucose and lipid abnormalities in patients with type 2 diabetes.
A second phase II study, known as SIR ( Study in Insulin Resistance ), examined the effect of Galida on lipid and glucose abnormalities in non-diabetic patients who exhibited manifestations of insulin resistance.
GLAD, Glucose and Lipid Assessment in Diabetes
GLAD was a 12-week, randomized, double-blind, placebo-controlled, phase II, dose-ranging study in 500 patients with type 2 diabetes.
The primary study objective was to observe the effect of Galida on fasting plasma glucose, across a dose range of 0.1 mg ( n=72 ), 0.5 mg ( n=73 ), 1.0 mg ( n=70 ), 2.0 mg ( n=70 ), and 3.0 mg ( n=73 ), compared to placebo ( n=70 ).
Secondary endpoints in the study included lipid variables, fasting plasma insulin, and HOMA.
Based on the results observed in the GLAD study, the 0.5 mg and 1.0 mg doses of Galida were taken forward in the phase III development.
Treatment with Galida resulted in the following placebo-corrected results:
- A dose-dependent reduction in fasting plasma glucose of up to 61 mg/dL ( p