| Trial ID: | L2928 |
| Source ID: | NCT00252772
|
| Associated Drug: |
Tesaglitazar
|
| Title: |
GALLANT 2 Tesaglitazar vs. Placebo
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Tesaglitazar|BEHAVIORAL: Dietary and Lifestyle counseling
|
| Outcome Measures: |
Primary: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) | Secondary: 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|Fibrinogen|Proportion of patients with microalbuminuria|Waist/hip ratio|Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values|Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C|Pharmacokinetics of tesaglitazar|Safety and tolerability of tesaglitazar by assessment of adverse events , laboratory values, electrocardiogram,, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination|Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
80
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-09
|
| Completion Date: |
2006-11
|
| Results First Posted: |
|
| Last Update Posted: |
2009-04-22
|
| Locations: |
Research Site, Hanko, Finland|Research Site, Helsinki, Finland|Research Site, Imatra, Finland|Research Site, Kokkola, Finland|Research Site, Kuopio, Finland|Research Site, Lahti, Finland|Research Site, Mikkeli, Finland|Research Site, Oulu, Finland|Research Site, Pattijoki, Finland|Research Site, Pietarsaari, Finland|Research Site, Pori, Finland|Research Site, Tampere, Finland|Research Site, Turku, Finland|Research Site, Ödet, Finland
|
| URL: |
https://clinicaltrials.gov/show/NCT00252772
|
