Trials Sponsors Conditions Drugs Pricing

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

The change in HDL-C from baseline to the end of the randomized treatment period.

Secondary Outcomes (8)

Changes in the following variables from baseline to the end of the randomized treatment period:
Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
+3 more secondary outcomes

Interventions

TesaglitazarDrug

MetforminDrug

FenofibrateDrug

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 (152)

Research Site

Fortaleza, Ceará, Brazil

Research Site

Goiânia, Goiás, Brazil

Research Site

Porto Alegre, Rio Grande do Sul, Brazil

Research Site

São Paulo, São Paulo, Brazil

Research Site

Curitiba, Brazil

Research Site

Calgary, Alberta, Canada

Research Site

Surrey, British Columbia, Canada

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesaglitazarMetforminFenofibrate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

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

December 1, 2005

First Posted

December 5, 2005

Study Start

March 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2006

Actual (reported)

Study Stopped

GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (152)

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

Study Stopped

GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (152)

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