GALLANT 2 Tesaglitazar vs. Placebo

Tracking Information
First Submitted Date ICMJE	November 10, 2005
First Posted Date ICMJE	November 15, 2005
Last Update Posted Date	April 22, 2009
Study Start Date ICMJE	September 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: November 10, 2005)	Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00252772 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 27, 2006)	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)
Original Secondary Outcome Measures ICMJE; (submitted: November 10, 2005)	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)
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	GALLANT 2 Tesaglitazar vs. Placebo
Official Title ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Type 2 Diabetes
Intervention ICMJE	Drug: Tesaglitazar; Behavioral: Dietary and Lifestyle counseling
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Enrollment ICMJE; (submitted: November 10, 2005)	80
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	November 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Provision of a written informed consent; Men or women who are >=18 years of age; Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control; Diagnosed with type 2 diabetes; Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents; Drug-naïve (ie, no use of antidiabetic drug[s] for at least 24 weeks prior to visit 1). Exclusion Criteria: Type 1 diabetes; New York Heart Association heart failure Class III or IV; Treatment with chronic insulin; History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin); History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells); Creatinine levels above twice the normal range; Creatine kinase above 3 times the upper limit of normal; Received any investigational product in other clinical studies within 12 weeks; Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Finland
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00252772
Other Study ID Numbers ICMJE	D6160C00026
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	AstraZeneca
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
PRS Account	AstraZeneca
Verification Date	April 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP