Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tesaglitazar Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight

Secondary Outcome Measures :
  1. Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on
  2. Time to treatment failure
  3. Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)
  4. Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG
  5. Markers of insulin resistance by assessment of insulin homeostasis assessment model
  6. Preventing beta-cell function by assessment of changes in the ratios proinsulin/insulin and C-peptide/FPG
  7. 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
  8. Responder rates and proportion of patients who reach pre-specified target levels for triglyceride and HDL-C
  9. Inflammatory and coagulability markers by assessment of C-reactive protein, fibrinogen, tumor necrosis factor-alpha, and intracellular adhesion molecule-1
  10. Urinary albumin excretion
  11. Central obesity (waist circumference, hip circumference and waist/hip ratio)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300105


Locations
Layout table for location information
Belgium
Research Site
Hasselt, Belgium
Research Site
Liege, Belgium
Research Site
Sint-Gillis-Waas, Belgium
Research Site
Steenokkerzeel, Belgium
Hong Kong
Research Site
Shatin, Hong Kong
Hungary
Research Site
Balatonfured, Hungary
Research Site
Budapest, Hungary
Research Site
Kaposvar, Hungary
Research Site
Kecskemet, Hungary
Research Site
Székesfehérvár, Hungary
Italy
Research Site
Gubbio, Italy
Research Site
Milano, Italy
Research Site
Perugia, Italy
Research Site
Piacenza, Italy
Research Site
Reggio Emilia, Italy
Research Site
Udine, Italy
Malaysia
Research Site
Kubang Kerian, Kelantan, Malaysia
Research Site
Kuala Lumpur, Malaysia
Philippines
Research Site
Makati City, Philippines
Research Site
Manila, Philippines
Research Site
Pasig City, Philippines
Poland
Research Site
Kraków, Poland
Research Site
Lublin, Poland
Research Site
Plock, Poland
Research Site
Torun, Poland
Research Site
Tychy, Poland
Research Site
Warszawa, Poland
Research Site
£ód?, Poland
Slovakia
Research Site
Banská Bystrica, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Ilava, Slovakia
Research Site
Kosice, Slovakia
Research Site
Kysucke Nove Mesto, Slovakia
Research Site
Lubochna, Slovakia
Research Site
Lucenec, Slovakia
Research Site
Nitra, Slovakia
Research Site
Presov, Slovakia
Research Site
Trnava, Slovakia
South Africa
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Cape Town, South Africa
Research Site
Durban, South Africa
Thailand
Research Site
Bangkok, Thailand
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00300105    
Other Study ID Numbers: D6160C00047
EudraCT No 2004-005243-97
First Posted: March 8, 2006    Key Record Dates
Last Update Posted: March 17, 2008
Last Verified: March 2008
Keywords provided by AstraZeneca:
Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 4
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases