Dose Response Study in Japanese Patients

Type 2 Diabetes Clinical Trial

Official title:

A Randomized, Double-Blind, Multicentre, Placebo-Controlled Study to Evaluate the Efficacy, Dose-Response and Safety of Tesaglitazar Therapy in Japanese Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00261417
• Other study ID #: D6160L00001
• Secondary ID: SH-SBD-0013
• Status: Terminated
• Phase: Phase 2
• First received: December 1, 2005
• Last updated: April 21, 2009
• Start date: May 2004
• Est. completion date: October 2005

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This is a 12-week study to determine the effect on glucose and lipids, safety, and tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week follow-up.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 250
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Provision of a written informed consent

• Men or women who are >=18 years of age

• Female patients: postmenopausal, hysterectomized

• Diagnosed with type 2 diabetes

• Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral anti-diabetic 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), 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

Locations

Country	Name	City	State
Japan	Research Site	Ashino
Japan	Research Site	Fuchu Keijinkai
Japan	Research Site	Fujimino
Japan	Research Site	Hijirino Koike
Japan	Research Site	Houseikai
Japan	Research Site	Hyuga
Japan	Research Site	Iriuchijima
Japan	Research Site	Iwase
Japan	Research Site	Kato
Japan	Research Site	Kawamata
Japan	Research Site	Keishukai Shirakawa
Japan	Research Site	Koga
Japan	Research Site	Kouhoku
Japan	Research Site	Kousei
Japan	Research Site	Kurosawa
Japan	Research Site	Nihonmatu
Japan	Research Site	Oki
Japan	Research Site	Saiseikai Fukuoka
Japan	Research Site	Sapporo
Japan	Research Site	Takamori

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-response relationship of tesaglitazar in subjects with type 2 diabetes by the assessment of the effects of each of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) to placebo with respect to fasting plasma glucose
Secondary	Changes in the following variables from baseline to the end of the randomized treatment period:
Secondary	Triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, total cholesterol apolipoproteins (Apo) (Apo A-I, Apo B and Apo CIII), and f
Secondary	Glucose and insulin values during an oral glucose tolerance test
Secondary	Effects on the reduction of insulin and glycosylated hemoglobin A1c levels
Secondary	Effects on the proportion of fasting plasma glucose responders
Secondary	Effects on the proportion of high-density lipoprotein cholesterol responders
Secondary	Effects on the changes from baseline in weight and waist/hip ratio
Secondary	Evaluate the pharmacokinetics of tesaglitazar
Secondary	Assess the safety and tolerability of tesaglitazar compared to placebo