Galida Trial Evaluates Glucose, Lipid Abnormalities in Type 2 Diabetes Patients

AstraZeneca has released the results of the Phase II dose finding study for Galida.

GLAD (Glucose and Lipid Assessment in Diabetes), a Phase II dose-ranging study, assessed the effects of Galida (tesaglitazar) on glucose and lipid abnormalities in patients with Type 2 diabetes.

The company also released data from a second Phase II study, known as SIR (Study in Insulin Resistance), which examined the effect of Galida on lipid and glucose abnormalities in nondiabetic patients who exhibited manifestations of insulin resistance. 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, 0.5 mg, 1 mg, 2 mg and 3 mg compared to placebo. 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 mg doses of Galida were taken forward in the Phase III development.