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GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00300105
Recruitment Status : Terminated (The development program has been terminated)
First Posted : March 8, 2006
Last Update Posted : March 17, 2008
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 7, 2006
First Posted Date  ICMJE March 8, 2006
Last Update Posted Date March 17, 2008
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2006)
Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2006)
  • Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
  • Time to treatment failure
  • Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
  • Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
  • Markers of insulin resistance by assessment of insulin homeostasis assessment model
  • Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
  • Changes in lipid variables (triglyceride, total cholesterol, high-density lipoprotein cholesterol [HDL-C], non-HDL-C, low-density lipoprotein cholesterol, low-density lipoprotein cholesterol/HDL-C, apolipoprotein [Apo] B, ApoA-1, ApoB/ApoA-1
  • Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
  • Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
  • Urinary albumin excretion
  • Central obesity (waist circumference, hip circumference and waist/hip ratio)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2006)
  • Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
  • - Time to treatment failure
  • - Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
  • - Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
  • - Markers of insulin resistance by assessment of insulin homeostasis assessment model
  • - Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
  • - Changes in lipid variables (triglyceride, total cholesterol, high-density lipoprotein cholesterol [HDL-C], non-HDL-C, low-density lipoprotein cholesterol, low-density lipoprotein cholesterol/HDL-C, apolipoprotein [Apo] B, ApoA-1, ApoB/ApoA-1
  • - Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
  • - Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
  • - Urinary albumin excretion
  • - Central obesity (waist circumference, hip circumference and waist/hip ratio)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes
Official Title  ICMJE A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar Therapy in Patients With Type 2 Diabetes
Brief Summary This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE 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
Study Arms  ICMJE 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: March 7, 2006)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 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
  • Completed the last two visits of randomized treatment period in GALLANT 4

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
  • Previous enrollment in this long-term extension study
  • 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Hong Kong,   Hungary,   Italy,   Malaysia,   Philippines,   Poland,   Slovakia,   South Africa,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00300105
Other Study ID Numbers  ICMJE D6160C00047
EudraCT No 2004-005243-97
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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 March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP