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A 24-Week Randomised, Double-Blind, 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 Insulin


Phase 3
18 Years
N/A
Not Enrolling
Both
Type 2 Diabetes Mellitus

Thank you

Trial Information

A 24-Week Randomised, Double-Blind, 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 Insulin


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 for less than 20 years and receiving at least 30 U
insulin per day

Exclusion Criteria:

- Type 1 diabetes

- New York Heart Association heart failure Class III or IV

- Treatment with any thiazolidinedione class of antidiabetic agents

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

AstraZeneca Galida Medical Sciences Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D6160C00033

NCT ID:

NCT00242372

Start Date:

August 2004

Completion Date:

March 2006

Related Keywords:

  • Type 2 Diabetes Mellitus
  • Insulin dependent Type 2 diabetes
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2

Name

Location

Research SiteAlabaster, Alabama  
Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteHays, Kansas  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteHooksett, New Hampshire  
Research SiteBelleville, New Jersey  
Research SiteAlbuquerque, New Mexico  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteEnid, Oklahoma  
Research SiteBend, Oregon  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteAppleton, Wisconsin