GALLANT 2 Tesaglitazar vs. Placebo

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

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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Tesaglitazar; Behavioral: Dietary and Lifestyle counseling

• Study Type: Interventional
• Enrollment: 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • 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
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Fibrinogen
Waist/hip ratio
Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Pharmacokinetics of tesaglitazar
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
Fasting plasma glucose (FPG), homeostatic model assessment, insulin, proinsulin, C-peptide
Proportion of patients with microalbuminuria
Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
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)

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion (ACTUAL): November 1, 2006

Study Registration Dates

• First Submitted: November 10, 2005
• First Submitted That Met QC Criteria: November 10, 2005
• First Posted (ESTIMATE): November 15, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): April 22, 2009
• Last Update Submitted That Met QC Criteria: April 21, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: D6160C00026