NCT00214565

TerminatedPhase 3

GALLANT 6 Tesaglitazar vs. Pioglitazone

AstraZeneca Source

AstraZeneca

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

D6160C00030

Study Type

interventional

Reported enrollment (type unavailable)

1,450

Locations

8 countries

Sites

74

Timeline

Study Start

August 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2006

Actual (reported)

Study Completion

October 2006

Actual (reported)

Brief Summary

This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Reported enrollment (type unavailable): 1,450 participants
Study completion date: October 2006
Actual (reported)
Listed locations: 8 countries · 74 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 20, 2005
Actual (reported)
First Posted
September 22, 2005
Actual (reported)
Primary Completion
October 2006
Actual (reported)
Study Completion
October 2006
Actual (reported)

Last Updated: November 19, 2010
Status Verified: November 2010
Last Update Submitted: November 17, 2010

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Secondary Outcomes (9)

The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Lipid parameters
FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
+4 more secondary outcomes

Interventions

GalidaDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Provision of a written informed consent
Men or women who are ³18 years of age

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (74)

Research Site

Altoona, Pennsylvania, United States

Research Site

Ciudad de Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research Site

Moron- Buenos Aires, Argentina

Research Sites

Quilmes - Buenos Aires, Argentina

Research Site

Rosario, Argentina

Research Site

Salta, Argentina

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesaglitazar

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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

September 20, 2005

First Posted

September 22, 2005

Study Start

August 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2006

Actual (reported)

NCT00255541

GALLANT 4 Tesaglitazar vs. Glibenclamide

Phase 3Terminated

NCT00242372

GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin

Phase 3Terminated

NCT00252772

GALLANT 2 Tesaglitazar vs. Placebo

Phase 3Terminated

NCT00252837

GALLANT 22 Tesaglitazar vs. Placebo

Phase 3Terminated

NCT00261352

GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

Phase 3Terminated

NCT00229710

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

Phase 3Terminated

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

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
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

Contact the study team to confirm eligibility.

Research Site

Curitiba, Brazil

Research Site

Edmonton, Alberta, Canada

Research Site

Abbotsford British Columbia, British Columbia, Canada

Research Site

Chilliwack, British Columbia, Canada

Research Site

Vancouver, British Columbia, Canada

Research Site

Victoria, British Columbia, Canada

Research Site

Dartmouth, Nova Scotia, Canada

Research Site

Halifax, Nova Scotia, Canada

Research Site

Truro, Nova Scotia, Canada

Research Site

Windsor, Nova Scotia, Canada

Research Site

Brampton, Ontario, Canada

Research Site

Etobicoke, Ontario, Canada

Research Site

Kingston, Ontario, Canada

Research Site

Niagara Falls, Ontario, Canada

Research Site

Oshawa, Ontario, Canada

Research Site

Scarborough Village, Ontario, Canada

Research Site

St. Catharines, Ontario, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Windsor, Ontario, Canada

Research Site

Trois-Rivières, Quebec, Canada

Research Site

Chicoutimi, Canada

Research Site

Longueuil, Canada

Research Site

Montreal, Canada

Research Site

St. John's, Canada

Research Site

Espoo, Finland

Research Site

Helsinki, Finland

Research Site

Kuopio, Finland

Research Site

Pietarsaar, Finland

Research Site

Pori, Finland

Research Site

Tampere, Finland

Research Site

Guadalajara Jalisco, Mexico

Research Site

Mexico City, Mexico

Research Site

México, Mexico

Research Site

Nuevo León, Mexico

Research Site

Puebla City, Mexico

Research Site

Torreón, Mexico

Research Site

Zapopan, Mexico

Research Site

Ås, Norway

Research Site

Bergen, Norway

Research Site

Elvernum, Norway

Research Site

Hamar, Norway

Research Site

Horten, Norway

Research Site

Kongsberg, Norway

Research Site

Lena, Norway

Research Site

Loeten, Norway

Research Site

Lysaker, Norway

Research Site

Oslo, Norway

Research Site

Osteraas, Norway

Research Site

Skedsmokorset, Norway

Research Site

Straume, Norway

Research Site

Tronheim, Norway

Research Site

Tønsberg, Norway

Research Site

Dublin, Ireland, United Kingdom

Research Site

Wexford, Ireland, United Kingdom

Research Site

Antrim, NI, United Kingdom

Research Site

Belfast, United Kingdom

Research Site

Cardiff, United Kingdom

Research Site

Edinburgh, United Kingdom

Research Site

Glasgow, United Kingdom

Research Site

Kent, United Kingdom

Research Site

Leeds, United Kingdom

Research Site

Mid Glamorgan, United Kingdom

Research Site

Pembrokeshire, United Kingdom

Research Site

Plymouth, United Kingdom

Research SIte

Reading, United Kingdom

Research Site

Surrey, United Kingdom

Research Site

Wiltshire, United Kingdom

Study Completion

October 2006

Actual (reported)

Last Updated

November 19, 2010

Record last verified: 2010-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00214565
Data provider: ClinicalTrials.gov
Source updated: 2010-11-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:08 UTC

Locations

AR(6)BR(1)CA(23)FI(6)GB(15)MX(7)NO(15)US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (74)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations