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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280865
• Other study ID #: SH-SBD-0001
• Secondary ID: GLAD
• Status: Completed
• Phase: Phase 2
• First received: January 20, 2006
• Last updated: July 27, 2006
• Start date: April 2002
• Est. completion date: June 2003

Study information

• Verified date: July 2006
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tesaglitazar

• Pioglitazone

Behavioral:
• Dietary and Lifestyle Modification Counseling

Locations

Country	Name	City	State
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Courtice	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Granby	Quebec
Canada	Research Site	Laval	Quebec
Canada	Research Site	Longueuil
Canada	Research Site	Montreal
Canada	Research Site	Sherbrooke
Canada	Research Site	Windsor
Canada	Research Site	Winnipeg
France	Research Site	Andard
France	Research Site	Angers
France	Research Site	Avrille
France	Research Site	Chalonnes-sur-Loire
France	Research Site	Montrevault
France	Research Site	Segre
France	Research Site	Tierce
Mexico	Research Site	Colonia Seccion XVI
Mexico	Research Site	Colonia Valle
Mexico	Research Site	Delegacion Cuauhtemoc
United States	Research Site	Albany	New York
United States	Research Site	Alhambra	California
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Anaheim	California
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Arlington	Texas
United States	Research Site	Atlanta	Georgia
United States	Research Site	Augusta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bangor	Maine
United States	Research Site	Birmingham	Alabama
United States	Research Site	Blue Ridge	Georgia
United States	Research Site	Brandon	Florida
United States	Research Site	Brooklyn	New York
United States	Research Site	Buffalo	New York
United States	Research Site	Cadillac	Michigan
United States	Research Site	Canfield	Ohio
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Cheswick	Pennsylvania
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbus	Ohio
United States	Research Site	Coral Gables	Florida
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	DeLand	Florida
United States	Research Site	Dinuba	California
United States	Research Site	Dunwoody	Georgia
United States	Research Site	Edmonds	Washington
United States	Research Site	Escondido	California
United States	Research Site	Eugene	Oregon
United States	Research Site	Evansville	Indiana
United States	Research Site	Falls Church	Virginia
United States	Research Site	Fresno	California
United States	Research Site	Gainesville	Florida
United States	Research Site	Greenbrae	California
United States	Research Site	Gurnee	Illinois
United States	Research Site	Henderson	Nevada
United States	Research Site	Hickory	North Carolina
United States	Research Site	Hollywood	Florida
United States	Research Site	Huntington	West Virginia
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jackson	Mississippi
United States	Research Site	Kettering	Ohio
United States	Research Site	Lakewood	Ohio
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lawrenceville	New Jersey
United States	Research Site	Long Beach	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Lubbock	Texas
United States	Research Site	Mesa	Arizona
United States	Research Site	Miami	Florida
United States	Research Site	Mission Viejo	California
United States	Research Site	Montgomery	Alabama
United States	Research Site	New Hyde Park	New York
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Newark	New Jersey
United States	Research Site	Ninety Six	South Carolina
United States	Research Site	Norfolk	Virginia
United States	Research Site	North Richland Hills	Texas
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orange	California
United States	Research Site	Pahrump	Nevada
United States	Research Site	Penndel	Pennsylvania
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Renton	Washington
United States	Research Site	Richmond	Virginia
United States	Research Site	Sacramento	California
United States	Research Site	Salisbury	Massachusetts
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Sioux Falls	South Dakota
United States	Research Site	Springfield	Illinois
United States	Research Site	St. Louis	Missouri
United States	Research Site	Stamford	Connecticut
United States	Research Site	Summerville	South Carolina
United States	Research Site	Tucson	Arizona
United States	Research Site	Walnut Creek	California
United States	Research Site	Warminster	Pennsylvania
United States	Research Site	Warwick	Rhode Island
United States	Research Site	Washington	District of Columbia
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Wichita	Kansas
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  France,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)
Secondary	Changes in the following variables from baseline to the end of the randomized treatment period:
Secondary	The change in plasma glucose and insulin during an oral glucose tolerance test
Secondary	Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Secondary	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
Secondary	Change in insulin levels and hemoglobin A1c (HbA1c) levels
Secondary	Responder analyses for FPG, TG, and HDL C according to pre-specified values
Secondary	Pharmacokinetics of tesaglitazar
Secondary	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
Secondary	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