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GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00280865
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : July 31, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 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 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Tesaglitazar Drug: Pioglitazone Behavioral: Dietary and Lifestyle Modification Counseling Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
Study Start Date : April 2002
Estimated Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)

Secondary Outcome Measures :
  1. Changes in the following variables from baseline to the end of the randomized treatment period:
  2. The change in plasma glucose and insulin during an oral glucose tolerance test
  3. Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
  4. 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
  5. Change in insulin levels and hemoglobin A1c (HbA1c) levels
  6. Responder analyses for FPG, TG, and HDL C according to pre-specified values
  7. Pharmacokinetics of tesaglitazar
  8. To assess the burden of type 2 diabetes mellitus in patients through the administration of the SF-36 health survey and the Well-Being Questionnaire (W BQ12) and comparing the study population data to published national and international normative data
  9. To evaluate diabetes-specific instruments, Audit of Diabetes Dependent Quality of Life (ADDQoL) and The Diabetes Treatment Satisfaction Questionnaire (DTSQ) (s and c) in the study population and estimate the effect size of the instruments in patients r

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of a written informed consent
  • Men or women who are 30 to 80 years of age
  • Female patients: postmenopausal or surgically sterile
  • Diagnosed with type 2 diabetes with C-peptide levels > 0.8 ng/mL
  • Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

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), or to other PPAR g or PPAR a and g agonists.
  • History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
  • Creatinine levels above 1.2 mg/dL
  • Received any investigational product in other clinical studies within 30 days
  • 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
Contacts and Locations

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): NCT00280865


  Show 110 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00280865     History of Changes
Other Study ID Numbers: SH-SBD-0001
GLAD
First Posted: January 24, 2006    Key Record Dates
Last Update Posted: July 31, 2006
Last Verified: July 2006

Keywords provided by AstraZeneca:
Tesaglitazar
type 2 diabetes

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