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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00229710
• Other study ID #: D6160C00049
• Status: Terminated
• Phase: Phase 3
• First received: September 28, 2005
• Last updated: November 18, 2010
• Start date: February 2005
• Est. completion date: December 2006

Study information

• Verified date: November 2010
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 270
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Tesaglitazar
0.5 in combination with insulin (with or without other oral antidiabetic drugs)

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Augusta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bellevue	Washington
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boise	Idaho
United States	Research Site	Brooklyn	New York
United States	Research Site	Cadillac	Michigan
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Cheswick	Pennsylvania
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago Heights	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbia	South Carolina
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dover	New Hampshire
United States	Research Site	Dunwoody	Georgia
United States	Research Site	Erie	Pennsylvania
United States	Research Site	Fort Worth	Texas
United States	Research Site	Fresno	California
United States	Research Site	Gainesville	Florida
United States	Research Site	Greenbrae	California
United States	Research Site	Greer	South Carolina
United States	Research Site	Gurnee	Illinois
United States	Research Site	Hollywood	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kettering	Ohio
United States	Research Site	La Jolla	California
United States	Research Site	Madison	Wisconsin
United States	Research Site	Medford	Oregon
United States	Research Site	Miami	Florida
United States	Research Site	New Hyde Park	New York
United States	Research Site	New Orleans	Louisiana
United States	Research Site	North Las Vegas	Nevada
United States	Research Site	Northridge	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orlando	Florida
United States	Research Site	Pahrump	Nevada
United States	Research Site	Palm Harbor	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Portland	Oregon
United States	Research Site	Renton	Washington
United States	Research Site	Richmond	Virginia
United States	Research Site	Richmond Heights	Missouri
United States	Research Site	Riverside	California
United States	Research Site	Roseland	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Santa Monica	California
United States	Research Site	Spokane	Washington
United States	Research Site	Spring Valley	California
United States	Research Site	Springfield	Illinois
United States	Research Site	St. Louis	Missouri
United States	Research Site	Tacoma	Washington
United States	Research Site	Toledo	Ohio
United States	Research Site	Tucson	Arizona
United States	Research Site	Walnut Creek	California
United States	Research Site	Washington	District of Columbia
United States	Research Site	Waterbury	Connecticut
United States	Research Site	West Hills	California
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wichita	Kansas
United States	Research Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events
Primary	Laboratory variables
Primary	Physical examination
Primary	Cardiac evaluation
Primary	Hypoglycemic events
Primary	Electrocardiogram
Primary	Vital signs (blood pressure and pulse)
Primary	Body weight
Secondary	Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Secondary	Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
Secondary	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
Secondary	C-reactive protein (CRP)
Secondary	Central obesity (waist circumference, hip circumference, waist/hip ratio)