Phase II Trial of GALIDA(TM) (tesaglitazar) Evaluates Glucose and Lipid Abnormalities in Type 2 Diabetes Patients

Phase II Trial of GALIDA(TM) (tesaglitazar) Evaluates Glucose and
Lipid Abnormalities in Type 2 Diabetes Patients 


SAN DIEGO, June 11  /PRNewswire-FirstCall/ -- AstraZeneca announced today, for
the first time, the results of the phase II dose finding study for GALIDA(TM)
(tesaglitazar), at the 65th annual American Diabetes Association (ADA)
Scientific Sessions in San Diego, CA.  GLAD (Glucose and Lipid Assessment in
Diabetes), a phase II dose-ranging study, assessed the effects of GALIDA on
glucose and lipid abnormalities in patients with type 2 diabetes. Also being
presented at the ADA are 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 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