GALLANT 2 Tesaglitazar vs. Placebo

This study has been terminated.
(The development program has been terminated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252772
First received: November 10, 2005
Last updated: April 21, 2009
Last verified: April 2009
  Purpose

This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6-week single-blind placebo run-in period followed by 24-week treatment period and a 3-week follow-up period.

The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.


Condition Intervention Phase
Type 2 Diabetes
Drug: Tesaglitazar
Behavioral: Dietary and Lifestyle counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Administered as Monotherapy to Drug-Naïve Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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:
  • 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
  • Fasting plasma glucose (FPG), homeostatic model assessment, insulin, proinsulin, C-peptide
  • Tumor necrosis factor-alpha, intracellular adhesion molecule-1
  • Fibrinogen
  • Proportion of patients with microalbuminuria
  • Waist/hip ratio
  • Responder analyses for HbA1c, FPG, TG, HDL C, 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
  • Patient-reported outcomes: Well-Being Questionnaire (W BQ12)

Estimated Enrollment: 80
Study Start Date: September 2004
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Drug-naïve (ie, no use of antidiabetic drug[s] for at least 24 weeks prior to visit 1).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252772

Locations
Finland
Research Site
Hanko, Finland
Research Site
Helsinki, Finland
Research Site
Imatra, Finland
Research Site
Kokkola, Finland
Research Site
Kuopio, Finland
Research Site
Lahti, Finland
Research Site
Mikkeli, Finland
Research Site
Oulu, Finland
Research Site
Pattijoki, Finland
Research Site
Pietarsaari, Finland
Research Site
Pori, Finland
Research Site
Tampere, Finland
Research Site
Turku, Finland
Research Site
Ödet, Finland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Galida Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00252772     History of Changes
Other Study ID Numbers: D6160C00026
Study First Received: November 10, 2005
Last Updated: April 21, 2009
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014