Trials Sponsors Conditions Drugs Pricing

Conditions

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 (14)

Changes in the following variables from baseline to the end of the randomized treatment period:
• 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 (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 c
• C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
+9 more secondary outcomes

Interventions

Tesaglitazar 0.5 or 1 mgDrug

Glibenclamide 2.5, 5, 10 or 15 mgDrug

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

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (84)

Research Site

Adelaide, Australia

Research Site

Brisbane, Australia

Research Site

Cairns, Australia

Research Site

Geelong, Australia

Research Site

Melbourne, Australia

Research Site

Perth, Australia

Research Site

Sydney, Australia

Research Site

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

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

November 9, 2005

First Posted

November 11, 2005

Study Start

July 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

March 2006

Actual (reported)

Study Stopped

GALLANT 7 Tesaglitazar Add-on to Sulphonylurea

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (84)

MeSH Terms

Conditions

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

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (84)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations