GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

Tracking Information
First Submitted Date ICMJE	September 23, 2005
First Posted Date ICMJE	September 27, 2005
Last Update Posted Date	November 19, 2010
Study Start Date ICMJE	March 2005
Actual Primary Completion Date	December 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 20, 2005)	Adverse events; Laboratory variables; Physical examination; Cardiac evaluation; Hypoglycemic events; Electrocardiogram; Vital signs (blood pressure and pulse); Body weight
Original Primary Outcome Measures ICMJE; (submitted: September 23, 2005)	Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Change History	Complete list of historical versions of study NCT00226330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 20, 2005)	Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c; Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C); Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C; C-reactive protein (CRP); Central obesity (waist circumference, hip circumference, waist/hip ratio); Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Original Secondary Outcome Measures ICMJE; (submitted: September 23, 2005)	Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c; Lipid variables (triglyderide, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C); Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for triglyceride, total cholesterol, low-density lipoprotein cholesterol, HDL-C and non-HDL-C; CRP; Central obesity (waist circumference, hip circumference, waist/hip ratio); Patient reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus
Official Title ICMJE	A Double-Blind, Multi-Centre, Active-Controlled (15, 30, and 45 mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Tesaglitazar (0.5 and 1 mg) in Patients With Type 2 Diabetes Mellitus (GALLEX 6)
Brief Summary	This is a parallel-group, multi-center, long-term extension study from the GALLANT 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.
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	Diabetes Mellitus, Type 2
Intervention ICMJE	Drug: Tesaglitazar (0.5 or 1 mg) Other Name: Galida; Drug: Pioglitazone (15, 30 or 45 mg) Other Name: Actos
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: September 23, 2005)	1100
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2006
Actual Primary Completion Date	December 2006 (Final data collection date for primary outcome measure)
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.; Completed the last two visits of the randomized treatment period in GALLANT 6 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, or neutropenia (low white blood cells); Creatinine levels of above twice the normal range; Creatine kinase of above 3 times the upper limit of normal; Previous enrollment in this long-term extension study; Any clinically significant abnormality identified by 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, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Argentina, Brazil, Canada, Finland, Mexico, United Kingdom, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00226330
Other Study ID Numbers ICMJE	D6160C00048
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: Galida Medical Science Director, MD AstraZeneca
PRS Account	AstraZeneca
Verification Date	November 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP