GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes

Treatments

Behavioral: Dietary and Lifestyle Modification Counseling

Drug: Pioglitazone

Drug: Tesaglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT00280865

GLAD

SH-SBD-0001

Details and patient eligibility

About

This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 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 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period

Sex

All

Ages

30 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of a written informed consent
Men or women who are 30 to 80 years of age
Female patients: postmenopausal or surgically sterile
Diagnosed with type 2 diabetes with C-peptide levels > 0.8 ng/mL
Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

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), or to other PPAR g or PPAR a and g agonists.
History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
Creatinine levels above 1.2 mg/dL
Received any investigational product in other clinical studies within 30 days
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