Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study GALLANT 6.

Outcome Measures

Primary Outcomes (8)

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

Secondary Outcomes (6)

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)
+1 more secondary outcomes

Interventions

TesaglitazarDrug

(0.5 or 1 mg)

Also known as: Galida

PioglitazoneDrug

(15, 30 or 45 mg)

Also known as: Actos

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 \>= 18 years of age

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (171)

Research Site

Birmingham, Alabama, United States

Research Site

Columbiana, Alabama, United States

Research Site

Mobile, Alabama, United States

Research Site

Chandler, Arizona, United States

Research Site

Mesa, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Sierra Vista, Arizona, United States

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesaglitazarPioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic Chemicals

Study Officials

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 23, 2005

First Posted

September 27, 2005

Study Start

March 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2006

Actual (reported)

Study Stopped

GALLEX 6: Study to Evaluate the Safety and Tolerability of Tesaglitazar in Patients With Type 2 Diabetes Mellitus

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (6)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (171)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

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 (8)

Secondary Outcomes (6)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (171)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations