GALLANT 5 Tesaglitazar Versus Metformin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A 52-wk Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin) Study to Evaluate the Efficacy, Safety & Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00214591
• Other study ID #: D6160C00029
• Status: Terminated
• Phase: Phase 3
• First received: September 20, 2005
• Last updated: November 18, 2010
• Start date: August 2004
• 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 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 580
• 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 ³18 years of age

• Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control

• Diagnosed with type 2 diabetes

• Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

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, neutropenia (low white blood cells)

• Creatinine levels above twice the normal range

• Creatine kinase above 3 times the upper limit of normal

• Received any investigational product in other clinical studies within 12 weeks

• 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: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• GALIDA

Locations

Country	Name	City	State
Finland	Research Site	Hämeenlinna
Finland	Research Site	Helsinki
Finland	Research Site	Joensuu
Finland	Research Site	Kouvola
Finland	Research Site	Kuopio
Finland	Research Site	Mikkeli
Finland	Research Site	Oulu
Finland	Research Site	Salo
Finland	Research Site	Tampere
Finland	Research Site	Vantaa
Germany	Research Site	Aschaffenburg
Germany	Research Site	Bad Segeberg
Germany	Research Site	Beckum
Germany	Research Site	Berlin
Germany	Research Site	Dresden
Germany	Research Site	Ehrenberg
Germany	Research Site	Essen
Germany	Research Site	Feldafing
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Hermaringen
Germany	Research Site	Künzing
Germany	Research Site	Langen
Germany	Research Site	Mannheim
Germany	Research Site	Marl
Germany	Research Site	Nürnberg
Germany	Research Site	Pirna
Germany	Research Site	Rotenburg/Fulda
Israel	Research Site	Ashkelon
Israel	Research Site	Haifa
Israel	Research Site	Holon
Israel	Research Site	Jerusalem
Israel	Research Site	Rishon-Lezion
Israel	Research Site	Tel Aviv
Israel	Research Site	Zefat
Netherlands	Research Site	Beek en Donk
Netherlands	Research Site	Bennebroe
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Deurne
Netherlands	Research Site	Huizen
Netherlands	Research Site	Losser
Netherlands	Research Site	Nijverdal
Netherlands	Research Site	Rijswijk
Netherlands	Research Site	Roelofarendsveen
Netherlands	Research Site	Rotterdam
Norway	Research Site	Bergen
Norway	Research Site	Oslo
Norway	Research Site	Østerås
Spain	Research Site	Alzira (Valencia)
Spain	Research Site	Barcelona
Spain	Research Site	Begonte (Lugo)
Spain	Research Site	Madrid
Spain	Research Site	San Vicente de Raspeig	Alicante
Spain	Research Site	Sevilla
Spain	Research Site	Villar del Arzobispo	Valencia
United Kingdom	Research Site	Aberdeen
United Kingdom	Research Site	Ayr
United Kingdom	Research Site	Bath
United Kingdom	Research Site	Berks
United Kingdom	Research Site	Bucks
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Manchester
United Kingdom	Research Sites	Northampton
United Kingdom	Research Site	Wiltshire
United States	Research Site	Albany	New York
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boise	Idaho
United States	Research Site	Bossier City	Louisiana
United States	Research Site	Bronx	New York
United States	Research Site	Brunswick	Georgia
United States	Research Site	Burke	Virginia
United States	Research Site	Carlisle	Arizona
United States	Research Site	Carollton	Georgia
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbiana	Alabama
United States	Research Site	Corpus Christi	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Escondido	California
United States	Research Site	Evansville	Indiana
United States	Research Site	Gainesville	Florida
United States	Research Site	Hamilton	New Jersey
United States	Research Site	Hollywood	Florida
United States	Research Site	Honolulu	Hawaii
United States	Research Site	Huntington Beach	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kalamazoo	Missouri
United States	Research Site	Kansas City	Kansas
United States	Research Site	Kettering	Ohio
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Los Angeles	California
United States	Research Site	Lubbock	Texas
United States	Research Site	Medford	Oregon
United States	Research Site	Menomonee Falls	Wisconsin
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Mission Viejo	California
United States	Research Site	Mobile	Alabama
United States	Research Site	Morristown	Tennessee
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Norfolk	Virginia
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Overland Park	Kansas
United States	Research Site	Pahrump	New York
United States	Research Site	Pasadena	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pomona	California
United States	Research Site	Redondo Beach	California
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Sacramento	California
United States	Research Site	San Antonio	Texas
United States	Research Center	Sherwood	Arizona
United States	Research Site	Simpsonville	South Carolina
United States	Research Site	Tacoma	Washington
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wheat Ridge	Colorado
United States	Research Site	White Plains	New York
United States	Research Site	Witchita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Finland,  Germany,  Israel,  Netherlands,  Norway,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary	The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Secondary	Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Secondary	Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and co
Secondary	C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Secondary	FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Secondary	Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Secondary	Fibrinogen
Secondary	Urinary albumin excretion
Secondary	Waist/hip ratio
Secondary	Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
Secondary	Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Secondary	Pharmacokinetics of tesaglitazar
Secondary	Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination