Clinical trial NCT00252772: GALLANT 2 Tesaglitazar vs. Placebo
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary outcomes:
measure: Changes in the following variables from baseline to the end of the randomized treatment period:
measure: 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
measure: C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
measure: Fasting plasma glucose (FPG), homeostatic model assessment, insulin, proinsulin, C-peptide
measure: Tumor necrosis factor-alpha, intracellular adhesion molecule-1
measure: Fibrinogen
measure: Proportion of patients with microalbuminuria
measure: Waist/hip ratio
measure: Responder analyses for HbA1c, FPG, TG, HDL C, non HDL C and LDL C according to pre-specified values
measure: Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
measure: Pharmacokinetics of tesaglitazar
measure: 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
measure: Patient-reported outcomes: Well-Being Questionnaire (W BQ12)
Other outcomes:
Locations:
city: Hanko
country: Finland
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Imatra
country: Finland
facility: Research Site
city: Kokkola
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Lahti
country: Finland
facility: Research Site
city: Mikkeli
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Pattijoki
country: Finland
facility: Research Site
city: Pietarsaari
country: Finland
facility: Research Site
city: Pori
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Ödet
country: Finland
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Galida Medical Science Director, MD
role: STUDY_DIRECTOR
References: