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GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00229710
Recruitment Status : Terminated (The development program has been terminated)
First Posted : September 30, 2005
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar 0.5mg When Added to Insulin Therapy in Patients With Type 2 Diabetes Mellitus (GALLEX 9)
Study Start Date : February 2005
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources


Intervention Details:
    Drug: Tesaglitazar
    0.5 in combination with insulin (with or without other oral antidiabetic drugs)
    Other Name: Galida


Primary Outcome Measures :
  1. Adverse events
  2. Laboratory variables
  3. Physical examination
  4. Cardiac evaluation
  5. Hypoglycemic events
  6. Electrocardiogram
  7. Vital signs (blood pressure and pulse)
  8. Body weight

Secondary Outcome Measures :
  1. Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
  2. Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
  3. 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
  4. C-reactive protein (CRP)
  5. Central obesity (waist circumference, hip circumference, waist/hip ratio)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 the randomized treatment period in GALLANT 9

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 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): NCT00229710


  Show 69 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00229710     History of Changes
Other Study ID Numbers: D6160C00049
First Posted: September 30, 2005    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Diabetes Mellitus, Type II
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs