Clinical trial NCT00280865: GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
Official title: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Tesaglitazar
type 2 diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-01-24
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG)
Secondary outcomes:
measure: Changes in the following variables from baseline to the end of the randomized treatment period:
measure: The change in plasma glucose and insulin during an oral glucose tolerance test
measure: Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
measure: 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
measure: Change in insulin levels and hemoglobin A1c (HbA1c) levels
measure: Responder analyses for FPG, TG, and HDL C according to pre-specified values
measure: Pharmacokinetics of tesaglitazar
measure: 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
measure: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Montgomery
country: United States
facility: Research Site
state: Alabama
city: Mesa
country: United States
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state: Arizona
city: Phoenix
country: United States
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state: Arizona
city: Tucson
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state: Arizona
city: Alhambra
country: United States
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state: California
city: Anaheim
country: United States
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state: California
city: Dinuba
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state: California
city: Escondido
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state: California
city: Fresno
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city: Greenbrae
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city: Long Beach
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city: Mission Viejo
country: United States
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city: Orange
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city: Sacramento
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city: San Diego
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city: Walnut Creek
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city: Stamford
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state: Connecticut
city: Waterbury
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city: Washington
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state: District of Columbia
city: Brandon
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city: Coral Gables
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city: DeLand
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city: Augusta
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city: Springfield
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city: Baltimore
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city: Salisbury
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city: Worcester
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city: Cadillac
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city: Henderson
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city: Las Vegas
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city: Newark
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city: New Hyde Park
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city: Cincinnati
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city: Cheswick
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city: Penndel
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city: Philadelphia
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state: Pennsylvania
city: Warminster
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state: Pennsylvania
city: Warwick
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state: Rhode Island
city: Columbia
country: United States
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state: South Carolina
city: Ninety Six
country: United States
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state: South Carolina
city: Summerville
country: United States
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state: South Carolina
city: Sioux Falls
country: United States
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state: South Dakota
city: Arlington
country: United States
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state: Texas
city: Corpus Christi
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: North Richland Hills
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Salt Lake City
country: United States
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state: Utah
city: Falls Church
country: United States
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state: Virginia
city: Norfolk
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state: Virginia
city: Richmond
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state: Virginia
city: Edmonds
country: United States
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state: Washington
city: Renton
country: United States
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state: Washington
city: Huntington
country: United States
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state: West Virginia
city: Edmonton
country: Canada
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state: Alberta
city: Burlington
country: Canada
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state: Ontario
city: Courtice
country: Canada
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state: Ontario
city: Granby
country: Canada
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state: Quebec
city: Laval
country: Canada
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state: Quebec
city: Longueuil
country: Canada
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city: Montreal
country: Canada
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city: Sherbrooke
country: Canada
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city: Windsor
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city: Winnipeg
country: Canada
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city: Andard
country: France
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city: Angers
country: France
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city: Avrille
country: France
facility: Research Site
city: Chalonnes-sur-Loire
country: France
facility: Research Site
city: Montrevault
country: France
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city: Segre
country: France
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city: Tierce
country: France
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city: Colonia Seccion XVI
country: Mexico
facility: Research Site
city: Colonia Valle
country: Mexico
facility: Research Site
city: Delegacion Cuauhtemoc
country: Mexico
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Goldstein BJ, Rosenstock J, Anzalone D, Tou C, Ohman KP. Effect of tesaglitazar, a dual PPAR alpha/gamma agonist, on glucose and lipid abnormalities in patients with type 2 diabetes: a 12-week dose-ranging trial. Curr Med Res Opin. 2006 Dec;22(12):2575-90. doi: 10.1185/030079906x154169.