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 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
+6 more secondary outcomes

Interventions

TesaglitazarDrug

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 (42)

Research Site

Hasselt, Belgium

Research Site

Liège, Belgium

Research Site

Sint-Gillis-Waas, Belgium

Research Site

Steenokkerzeel, Belgium

Research Site

Shatin, Hong Kong

Research Site

Balatonfüred, Hungary

Research Site

Budapest, Hungary

Research Site

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

March 7, 2006

First Posted

March 8, 2006

Study Start

October 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

December 2006

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (42)

MeSH Terms

Conditions

Interventions

Condition 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

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (42)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations