Clinical trial NCT00261417: Dose Response Study in Japanese Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 250
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: Changes in the following variables from baseline to the end of the randomized treatment period:
measure: 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
measure: Glucose and insulin values during an oral glucose tolerance test
measure: Effects on the reduction of insulin and glycosylated hemoglobin A1c levels
measure: Effects on the proportion of fasting plasma glucose responders
measure: Effects on the proportion of high-density lipoprotein cholesterol responders
measure: Effects on the changes from baseline in weight and waist/hip ratio
measure: Evaluate the pharmacokinetics of tesaglitazar
measure: Assess the safety and tolerability of tesaglitazar compared to placebo
Other outcomes:
Locations:
city: Ashino
country: Japan
facility: Research Site
city: Fuchu Keijinkai
country: Japan
facility: Research Site
city: Fujimino
country: Japan
facility: Research Site
city: Hijirino Koike
country: Japan
facility: Research Site
city: Houseikai
country: Japan
facility: Research Site
city: Hyuga
country: Japan
facility: Research Site
city: Iriuchijima
country: Japan
facility: Research Site
city: Iwase
country: Japan
facility: Research Site
city: Kato
country: Japan
facility: Research Site
city: Kawamata
country: Japan
facility: Research Site
city: Keishukai Shirakawa
country: Japan
facility: Research Site
city: Koga
country: Japan
facility: Research Site
city: Kouhoku
country: Japan
facility: Research Site
city: Kousei
country: Japan
facility: Research Site
city: Kurosawa
country: Japan
facility: Research Site
city: Nihonmatu
country: Japan
facility: Research Site
city: Oki
country: Japan
facility: Research Site
city: Saiseikai Fukuoka
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Research Site
city: Takamori
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Japan Medical Director, MD
role: STUDY_DIRECTOR
References: