The development program has been terminated
A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes
Sponsor study identifier
interventional
80
1 country
14
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
November 2006
Actual (reported)This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6-week single-blind placebo run-in period followed by 24-week treatment period and a 3-week follow-up period. The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
November 10, 2005
Actual (reported)November 15, 2005
Actual (reported)November 2006
Actual (reported)Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Changes in the following variables from baseline to the end of the randomized treatment period:
Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and c
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Fasting plasma glucose (FPG), homeostatic model assessment, insulin, proinsulin, C-peptide
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Site
Hanko, Finland
Research Site
Helsinki, Finland
Research Site
Imatra, Finland
Research Site
Jakobstad, Finland
Research Site
Kokkola, Finland
Research Site
Kuopio, Finland
Research Site
Lahti, Finland
Research Site
AstraZeneca Galida Medical Science Director, MD
AstraZeneca
First Submitted
November 10, 2005
First Posted
November 15, 2005
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
November 2006
Actual (reported)GALLANT 8 Tesaglitazar Add-on to Metformin
Contact the study team to confirm eligibility.
Mikkeli, Finland
Research Site
Oulu, Finland
Research Site
Ödet, Finland
Research Site
Pattijoki, Finland
Research Site
Pori, Finland
Research Site
Tampere, Finland
Research Site
Turku, Finland
Last Updated
April 22, 2009
Record last verified: 2009-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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