NCT00252772

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Sep 2004

Typical duration for phase_3 type-2-diabetes

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

First QC Date

November 10, 2005

Last Update Submit

April 21, 2009

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Interventions

TesaglitazarDRUG
Dietary and Lifestyle counselingBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Hanko, Finland

Location

Research Site

Helsinki, Finland

Location

Research Site

Imatra, Finland

Location

Research Site

Jakobstad, Finland

Location

Research Site

Kokkola, Finland

Location

Research Site

Kuopio, Finland

Location

Research Site

Lahti, Finland

Location

Research Site

Mikkeli, Finland

Location

Research Site

Oulu, Finland

Location

Research Site

Ödet, Finland

Location

Research Site

Pattijoki, Finland

Location

Research Site

Pori, Finland

Location

Research Site

Tampere, Finland

Location

Research Site

Turku, Finland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesaglitazarDiet

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • AstraZeneca Galida Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 15, 2005

Study Start

September 1, 2004

Study Completion

November 1, 2006

Last Updated

April 22, 2009

Record last verified: 2009-04

Locations

FI(14)