search
Back to results

GALLANT 7 Tesaglitazar Add-on to Sulphonylurea

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tesaglitazar 0.5 or 1 mg
Glibenclamide 2.5, 5, 10 or 15 mg
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provision of a written informed consent Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control Diagnosed with type 2 diabetes Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents Exclusion Criteria: Type 1 diabetes New York Heart Association heart failure Class III or IV Treatment with chronic insulin History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) Creatinine levels above twice the normal range Creatine kinase above 3 times the upper limit of normal Received any investigational product in other clinical studies within 12 weeks Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Outcomes

Primary Outcome Measures

Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)

Secondary Outcome Measures

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
• FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
• Tumor necrosis factor-alpha, intracellular adhesion molecule-1
• Fibrinogen
• Urinary albumin excretion
• Waist/hip ratio
• Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
• Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
• Pharmacokinetics of tesaglitazar
• Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination

Full Information

First Posted
November 9, 2005
Last Updated
March 14, 2008
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00251940
Brief Title
GALLANT 7 Tesaglitazar Add-on to Sulphonylurea
Official Title
A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Sulphonylurea Alone
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
The development program has been terminated
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
555 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tesaglitazar 0.5 or 1 mg
Intervention Type
Drug
Intervention Name(s)
Glibenclamide 2.5, 5, 10 or 15 mg
Primary Outcome Measure Information:
Title
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary Outcome Measure Information:
Title
Changes in the following variables from baseline to the end of the randomized treatment period:
Title
• The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Title
• Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Title
• 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
Title
• C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Title
• FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Title
• Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Title
• Fibrinogen
Title
• Urinary albumin excretion
Title
• Waist/hip ratio
Title
• Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
Title
• Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Title
• Pharmacokinetics of tesaglitazar
Title
• Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of a written informed consent Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control Diagnosed with type 2 diabetes Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents Exclusion Criteria: Type 1 diabetes New York Heart Association heart failure Class III or IV Treatment with chronic insulin History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) Creatinine levels above twice the normal range Creatine kinase above 3 times the upper limit of normal Received any investigational product in other clinical studies within 12 weeks Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Galida Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Adelaide
Country
Australia
Facility Name
Research Site
City
Brisbane
Country
Australia
Facility Name
Research Site
City
Cairns
Country
Australia
Facility Name
Research Site
City
Geelong
Country
Australia
Facility Name
Research Site
City
Melbourne
Country
Australia
Facility Name
Research Site
City
Perth
Country
Australia
Facility Name
Research Site
City
Sydney
Country
Australia
Facility Name
Research Site
City
Tasmania
Country
Australia
Facility Name
Research Site
City
Angers
Country
France
Facility Name
Research Site
City
Hyeres
Country
France
Facility Name
Research Site
City
La Garde
Country
France
Facility Name
Research Site
City
La Seyne Sur Mer
Country
France
Facility Name
Research Site
City
Laval
Country
France
Facility Name
Research Site
City
Le Brusc
Country
France
Facility Name
Research Site
City
Le Lavandou
Country
France
Facility Name
Research Site
City
Montrevault
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Saint-Cyr
Country
France
Facility Name
Research Site
City
Six Fours Les Plages
Country
France
Facility Name
Research Site
City
Tierce
Country
France
Facility Name
Research Site
City
Toulon
Country
France
Facility Name
Research Site
City
Ashkelon
Country
Israel
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Holon
Country
Israel
Facility Name
Research Site
City
Jerusalem
Country
Israel
Facility Name
Research Site
City
Rishon-Lezion
Country
Israel
Facility Name
Research Site
City
Tel Aviv
Country
Israel
Facility Name
Research Site
City
Tel Hashomer
Country
Israel
Facility Name
Research Site
City
Zefat
Country
Israel
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon
Country
Korea, Republic of
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Elverum
Country
Norway
Facility Name
Research Site
City
Enebakk
Country
Norway
Facility Name
Research Site
City
Fredrikstad
Country
Norway
Facility Name
Research Site
City
Gamle Fredrikstad
Country
Norway
Facility Name
Research Site
City
Hamar
Country
Norway
Facility Name
Research Site
City
Haugesund
Country
Norway
Facility Name
Research Site
City
Hurdal
Country
Norway
Facility Name
Research Site
City
Inderøy
Country
Norway
Facility Name
Research Site
City
Lena
Country
Norway
Facility Name
Research Site
City
Levanger
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Rud
Country
Norway
Facility Name
Research Site
City
Sedsmokorset
Country
Norway
Facility Name
Research Site
City
Soerumsand
Country
Norway
Facility Name
Research Site
City
Stavanger
Country
Norway
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Marikina City
Country
Philippines
Facility Name
Research Site
City
Pasig City
Country
Philippines
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Chatsworth
Country
South Africa
Facility Name
Research Site
City
Gauteng
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Alzira (Valencia)
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Guissona (Lleida)
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
San Sebastian de los Reyes ( Madrid)
Country
Spain
Facility Name
Research Site
City
San Vicente de Raspeig (Alicante)
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Dublin
State/Province
Ireland
Country
United Kingdom
Facility Name
Research Site
City
Aberdeen
Country
United Kingdom
Facility Name
Research Site
City
Barnsley
Country
United Kingdom
Facility Name
Research Site
City
Bath
Country
United Kingdom
Facility Name
Research Site
City
Belfast
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
Country
United Kingdom
Facility Name
Research Site
City
Cardiff
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Dundee
Country
United Kingdom
Facility Name
Research Site
City
East Sussex
Country
United Kingdom
Facility Name
Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Leeds
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Shrewsbury
Country
United Kingdom
Facility Name
Research Site
City
Surrey
Country
United Kingdom
Facility Name
Research Site
City
West Midlands
Country
United Kingdom
Facility Name
Research Site
City
Wiltshire
Country
United Kingdom
Facility Name
Research Site
City
Wrexham
Country
United Kingdom
Facility Name
Research Site
City
Hanoi
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
Country
Vietnam

12. IPD Sharing Statement

Learn more about this trial

GALLANT 7 Tesaglitazar Add-on to Sulphonylurea

We'll reach out to this number within 24 hrs