GALLANT 2 Tesaglitazar vs. Placebo

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00252772
• Other study ID #: D6160C00026
• Status: Terminated
• Phase: Phase 3
• First received: November 10, 2005
• Last updated: April 21, 2009
• Start date: September 2004
• Est. completion date: November 2006

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Tesaglitazar

Behavioral:
• Dietary and Lifestyle counseling

Locations

Country	Name	City	State
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	Ödet
Finland	Research Site	Oulu
Finland	Research Site	Pattijoki
Finland	Research Site	Pietarsaari
Finland	Research Site	Pori
Finland	Research Site	Tampere
Finland	Research Site	Turku

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary	Changes in the following variables from baseline to the end of the randomized treatment period:
Secondary	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
Secondary	C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
Secondary	Fasting plasma glucose (FPG), homeostatic model assessment, insulin, proinsulin, C-peptide
Secondary	Tumor necrosis factor-alpha, intracellular adhesion molecule-1
Secondary	Fibrinogen
Secondary	Proportion of patients with microalbuminuria
Secondary	Waist/hip ratio
Secondary	Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
Secondary	Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
Secondary	Pharmacokinetics of tesaglitazar
Secondary	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
Secondary	Patient-reported outcomes: Well-Being Questionnaire (W BQ12)