Clinical trial NCT00229710: GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type II
Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-30
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Adverse events
measure: Laboratory variables
measure: Physical examination
measure: Cardiac evaluation
measure: Hypoglycemic events
measure: Electrocardiogram
measure: Vital signs (blood pressure and pulse)
measure: Body weight
Secondary outcomes:
measure: Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
measure: Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
measure: 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
measure: C-reactive protein (CRP)
measure: Central obesity (waist circumference, hip circumference, waist/hip ratio)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Fresno
country: United States
facility: Research Site
state: California
city: Greenbrae
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Northridge
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: West Hills
country: United States
facility: Research Site
state: California
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Palm Harbor
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Dunwoody
country: United States
facility: Research Site
state: Georgia
city: Boise
country: United States
facility: Research Site
state: Idaho
city: Chicago Heights
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Gurnee
country: United States
facility: Research Site
state: Illinois
city: Springfield
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Cadillac
country: United States
facility: Research Site
state: Michigan
city: Richmond Heights
country: United States
facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: North Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Pahrump
country: United States
facility: Research Site
state: Nevada
city: Dover
country: United States
facility: Research Site
state: New Hampshire
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Kettering
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: Cheswick
country: United States
facility: Research Site
state: Pennsylvania
city: Erie
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Corpus Christi
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Roseland
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Renton
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: