Trials Sponsors Conditions Drugs Pricing

Conditions

Type 2 Diabetes Mellitus

Keywords

Insulin dependent 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 (15)

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 from baseline to the end of the randomized treatment period
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model from baseline to the end of the randomized treatment period
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
+10 more secondary outcomes

Interventions

Tesaglitazar 0.5Drug

Insulin at least 30 units/dayDrug

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 (71)

Research Site

Birmingham, Alabama, United States

Research Site

Phoenix, Arizona, United States

Research Site

Tuscson, Arizona, United States

Research Site

Fresno, California, United States

Research Site

Greenbrae, California, United States

Research Site

La Jolla, California, United States

Research Site

Northridge, California, United States

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 Sciences 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

October 19, 2005

First Posted

October 20, 2005

Study Start

August 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

March 2006

Actual (reported)

Study Stopped

GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin

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 (15)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (71)

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

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (71)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations