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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tesaglitazar
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

Primary Outcome Measures

Adverse events
Laboratory variables
Physical examination
Cardiac evaluation
Hypoglycemic events
Electrocardiogram
Vital signs (blood pressure and pulse)
Body weight

Secondary Outcome Measures

Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
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
C-reactive protein (CRP)
Central obesity (waist circumference, hip circumference, waist/hip ratio)

Full Information

First Posted
September 28, 2005
Last Updated
November 18, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00229710
Brief Title
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

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
The development program has been terminated
Study Start Date
February 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
270 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tesaglitazar
Other Intervention Name(s)
Galida
Intervention Description
0.5 in combination with insulin (with or without other oral antidiabetic drugs)
Primary Outcome Measure Information:
Title
Adverse events
Title
Laboratory variables
Title
Physical examination
Title
Cardiac evaluation
Title
Hypoglycemic events
Title
Electrocardiogram
Title
Vital signs (blood pressure and pulse)
Title
Body weight
Secondary Outcome Measure Information:
Title
Pharmacodynamic: fasting plasma glucose, glycosylated hemoglobin A1c
Title
Lipid variables (triglyceride, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and non-HDL-C)
Title
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
Title
C-reactive protein (CRP)
Title
Central obesity (waist circumference, hip circumference, waist/hip ratio)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Galida Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Birmingham
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Alabama
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United States
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Phoenix
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United States
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Tucson
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Arizona
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United States
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Fresno
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California
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United States
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Greenbrae
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California
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United States
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La Jolla
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California
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United States
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Northridge
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United States
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Riverside
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California
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United States
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San Diego
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California
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United States
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Santa Monica
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California
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United States
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Spring Valley
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California
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United States
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Walnut Creek
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California
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United States
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West Hills
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California
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United States
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Waterbury
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Connecticut
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United States
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Washington
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District of Columbia
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United States
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Gainesville
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Florida
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United States
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Hollywood
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Florida
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United States
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Jacksonville
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Florida
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United States
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Miami
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Florida
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United States
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Orlando
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United States
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Palm Harbor
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United States
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West Palm Beach
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United States
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Augusta
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Georgia
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United States
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Dunwoody
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Georgia
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Boise
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Idaho
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United States
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Chicago Heights
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Illinois
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United States
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Chicago
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Illinois
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United States
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Gurnee
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United States
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Springfield
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United States
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Indianapolis
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Wichita
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New Orleans
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Cadillac
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Richmond Heights
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St. Louis
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Omaha
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North Las Vegas
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Pahrump
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Dover
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United States
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Albuquerque
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United States
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Brooklyn
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United States
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New Hyde Park
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New York
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Charlotte
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North Carolina
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United States
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Wilmington
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United States
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Cincinnati
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United States
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Kettering
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United States
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Toledo
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United States
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Oklahoma City
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Medford
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Portland
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Altoona
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United States
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Cheswick
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United States
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Erie
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United States
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Philadelphia
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United States
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Columbia
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South Carolina
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United States
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Greer
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South Carolina
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United States
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Corpus Christi
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Texas
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United States
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Dallas
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Texas
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United States
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Fort Worth
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Houston
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Roseland
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San Antonio
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Richmond
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Virginia
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Bellevue
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United States
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Renton
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United States
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Spokane
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United States
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Tacoma
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United States
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Madison
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Wisconsin
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United States

12. IPD Sharing Statement

Learn more about this trial

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

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