GALLANT 8 Tesaglitazar Add-on to Metformin

Overview[ - collapse ][ - ]

Purpose 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
ConditionType 2 Diabetes
InterventionDrug: Tesaglitazar
Drug: Metformin
PhasePhase 3
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00251953
First ReceivedNovember 9, 2005
Last UpdatedApril 21, 2009
Last verifiedApril 2009

Tracking Information[ + expand ][ + ]

First Received DateNovember 9, 2005
Last Updated DateApril 21, 2009
Start DateJuly 2004
Estimated Primary Completion DateMarch 2006
Current Primary Outcome MeasuresAbsolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Current Secondary Outcome Measures
  • Changes in the following variables from baseline to the end of the randomized treatment period:
  • 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

Descriptive Information[ + expand ][ + ]

Brief TitleGALLANT 8 Tesaglitazar Add-on to Metformin
Official TitleA 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 Metformin Alone
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 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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: Tesaglitazar
Drug: Metformin
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment555
Estimated Completion DateMarch 2006
Estimated Primary Completion DateNot Provided
Eligibility Criteria
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesAustralia, Canada, Finland, Germany, India, Italy, Malaysia, Philippines, Singapore, Sweden, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT00251953
Other Study ID NumbersD6160C00031
Has Data Monitoring CommitteeNot Provided
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsNot Provided
Investigators Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
Verification DateApril 2009

Locations[ + expand ][ + ]

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
Coquitlam, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Hastings, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
North York, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Smith Falls, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Chomedey-Laval, Quebec, Canada
Research Site
Laval, Quebec, Canada
Research Site
Montréal, Quebec, Canada
Research Site
Helsinki, Finland
Research Site
Hämeenlinna, 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, Finland
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, Germany
Research Site
Bangalore, India
Research Site
Hyderabad, India
Research Site
New Delhi, India
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, Italy
Research Site
Kubang Kerian, Kota Bharu, Malaysia
Research Site
Kuala Lumpur, Malaysia
Research Site
Cebu City, Philippines
Research Site
Quezon City, Philippines
Research Site
Singapore, Singapore
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, Sweden
Research Site
Ängelholm, Sweden
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, United Kingdom