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

Phase 3

Terminated

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00229710
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-28
• Study First Submitted QC: 2005-09-28
• Study First Posted: 2005-09-30
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-18
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 270

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Madison, Wisconsin, United States