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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00251953
Other study ID # D6160C00031
Secondary ID EudraCT No 2004-
Status Terminated
Phase Phase 3
First received November 9, 2005
Last updated April 21, 2009
Start date July 2004
Est. completion date March 2006

Study information

Verified date April 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Study type Interventional

Clinical Trial 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 metformin in patients with type 2 diabetes, not adequately controlled on optimized metformin 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


Recruitment information / eligibility

Status Terminated
Enrollment 555
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Provision of a written informed consent

- Men or women who are >=18 years of age

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tesaglitazar

Metformin


Locations

Country Name City State
Australia 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
Canada Research Site Chomedey-Laval Quebec
Canada Research Site Coquitlam British Columbia
Canada Research Site Etobicoke Ontario
Canada Research Site Hamilton Ontario
Canada Research Site Hastings Ontario
Canada Research Site Kingston Ontario
Canada Research Site Laval Quebec
Canada Research Site Montréal Quebec
Canada Research Site North York Ontario
Canada Research Site Ottawa Ontario
Canada Research Site Smith Falls Ontario
Canada Research Site St. John's Newfoundland and Labrador
Canada Research Site Toronto Ontario
Canada Research Site Winnipeg Manitoba
Finland Research Site Hämeenlinna
Finland Research Site Helsinki
Finland Research Site Joensuu
Finland Research Site Kouvola
Finland Research Site Kuopio
Finland Research Site Mikkeli
Finland Research Site Oulu
Finland Research Site Salo
Finland Research Site Tampere
Finland Research Site Vantaa
Germany Research Site Aschaffenburg
Germany Research Site Berlin
Germany Research Site Essen
Germany Research Site Hamburg
Germany Research Site Heidelberg
Germany Research Site Mannheim
Germany Research Site Nürberg
Germany Research Site Rotenburg/Fulda
India Research Site Bangalore
India Research Site Hyderabad
India Research Site New Delhi
Italy Research Site Arenzano
Italy Research Site Chiavari (GE)
Italy Research Site Chieri
Italy Research Site Desio
Italy Research Site Firenze
Italy Research Site Gubbio
Italy Research Site Marsala
Italy Research Site Messina
Italy Research Site Milano
Italy Research Site Monteccio Emilia
Italy Research Site Napoli
Italy Research Site Padova
Italy Research Site Perugia
Italy Research Site Pescara
Italy Research Site Piacenza
Italy Research Site Pistoia
Italy Research Site Reggio Calabria
Italy Research Site Reggio Emilia
Italy Research Site Rho
Italy Research Site Roma
Italy Research Site Scandiano
Italy Research Site Udine
Malaysia Research Site Kuala Lumpur
Malaysia Research Site Kubang Kerian Kota Bharu
Philippines Research Site Cebu City
Philippines Research Site Quezon City
Singapore Research Site Singapore
Sweden Research Site Ängelholm
Sweden Research Site Borås
Sweden Research Site Dalby
Sweden Research Site Göteborg
Sweden Research Site Höganäs
Sweden Research Site Kungsör
Sweden Research Site Malmö
Sweden Research Site Mölndal
Sweden Research Site Oskarshamn
Sweden Research Site Skene
Sweden Research Site Skrivarp
Sweden Research Site Stenungsund
Sweden Research Site Uppsala
United Kingdom Research Site Aberdeen
United Kingdom Research Site Aldershot
United Kingdom Research Site Atherstone
United Kingdom Research Site Barry
United Kingdom Research Site Bath
United Kingdom Research Site Bexhill-on-Sea
United Kingdom Research Site Birmingham
United Kingdom Research Site Bolton
United Kingdom Research Site Cardiff
United Kingdom Research Site Chippenham
United Kingdom Research Site Coventry
United Kingdom Research Site Dundee
United Kingdom Research Site Edinburgh
United Kingdom Research Site Glasgow
United Kingdom Research Site Harrow
United Kingdom Research Site Hastings
United Kingdom Research Site Leeds
United Kingdom Research Site Liverpool
United Kingdom Research Site Manchester
United Kingdom Research Site Plymouth
United Kingdom Research Site Radstock
United Kingdom Research Site Slough
United Kingdom Research Site Swindon
United Kingdom Research Site West Midlands
United Kingdom Research Site Wrexham

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Canada,  Finland,  Germany,  India,  Italy,  Malaysia,  Philippines,  Singapore,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary Changes in the following variables from baseline to the end of the randomized treatment period:
Secondary Fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Secondary Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Secondary 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
Secondary C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Secondary FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Secondary Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Secondary Fibrinogen
Secondary Urinary albumin excretion
Secondary Waist/hip ratio
Secondary Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
Secondary Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Secondary Pharmacokinetics of tesaglitazar
Secondary 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
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