Phase II Trial of GALIDA(TM) (tesaglitazar) Evaluates Glucose and Lipid Abnormalities in Type 2 Diabetes Patients
11 Juin 2005 - 7:30PM
PR Newswire (US)
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