GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes

NCT00300105 | Terminated Phase 3

• 2 other identifiers: D6160C00047EudraCT No 2004-005243-97
• Study Type: interventional
• Target: 400
• Locations: 10 countries
• Sites: 42

Brief Summary

This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 weeks.

Conditions

Type 2 Diabetes

Keywords

Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 4

Outcome Measures

Primary Outcomes (1)

• Adverse events, laboratory variables, physical examination, cardiac evaluation, hypoglycemic events, electrocardiogram, vital signs (blood pressure and pulse), body weight

Secondary Outcomes (11)

• Effect of tesaglitazar versus glibenclamide, with or without other oral anti-diabetic drugs on

• Time to treatment failure

• Changes in glycemic variables: glycosylated hemoglobin A1c and fasting plasma glucose (FPG)

• Responder rates and proportion of patients who reach pre-specified target levels for glycosylated hemoglobin A1c and FPG

• Markers of insulin resistance by assessment of insulin homeostasis assessment model

Interventions

Tesaglitazar DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 randomized treatment period in GALLANT 4

You may not qualify if:

• 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, neutropenia (low white blood cells)
• Creatinine levels above twice the normal range
• Creatine kinase 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (42)

Research Site

Hasselt, Belgium

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Liège, Belgium

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Sint-Gillis-Waas, Belgium

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Steenokkerzeel, Belgium

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Shatin, Hong Kong

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Balatonfüred, Hungary

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Budapest, Hungary

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Kaposvár, Hungary

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Kecskemét, Hungary

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Székesfehérvár, Hungary

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Gubbio, Italy

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Milan, Italy

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Perugia, Italy

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Piacenza, Italy

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Reggio Emilia, Italy

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Udine, Italy

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Kubang Kerian, Kelantan, Malaysia

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Kuala Lumpur, Malaysia

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Makati City, Philippines

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Manila, Philippines

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Pasig, Philippines

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Krakow, Poland

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Lublin, Poland

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Płock, Poland

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Torun, Poland

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Tychy, Poland

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Warsaw, Poland

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£ód?, Poland

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Banská Bystrica, Slovakia

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Bratislava, Slovakia

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Ilava, Slovakia

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Košice, Slovakia

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Kysucké Nové Mesto, Slovakia

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Lučenec, Slovakia

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Ľubochňa, Slovakia

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Nitra, Slovakia

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Prešov, Slovakia

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Trnava, Slovakia

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Johannesburg, Gauteng, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Bangkok, Thailand

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesaglitazar

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• AstraZeneca Galida Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 8, 2006
• Study Start: October 1, 2005
• Study Completion: December 1, 2006
• Last Updated: March 17, 2008

Record last verified: 2008-03

Locations

MY (2); PL (7); ZA (3); TH (1); PH (3); SL (10); HK (1); BE (4); HU (5); IT (6)