EUCTR2006-004694-97-HU进行中（未招募）不适用
A Phase IIb, 12-week, multicenter, randomized, double-blind, placebo-controlled,pioglitazone-controlled, parallel-group dose-ranging study in approximately 336 maleand female subjects, aged 18 to 70 years with type 2 diabetes mellitus who are treatmentnaïve.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the Investigator’s Brochure.
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1. Subjects with a documented diagnosis of T2DM and have an HbA1c level at Visits 1
- •and 2 of =7.5% and =9.5% as measured by a central laboratory.
- •2. Subjects who are treatment naïve, or who may have taken insulin or any oral
- •antidiabetic medications for a total of no more than 2 and 4 weeks respectively
- •within the previous 12 months, but not at all within the 3 months prior to screening,
- •or subjects who are newly diagnosed and treated with diet and exercise for a minimum of 8 weeks.
- •3. Subjects who are 18 to 70 years of age inclusive at the time of Screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. Metabolic Disease
- •Diagnosis of Type 1 diabetes mellitus.
- •History of ketoacidosis which has required hospitalization.
- •Thyroid disorder [TSH below the lower limit of the reference range (LLRR) of 0.4mIU/L or above the upper limit of the reference range (ULRR) of >5.5 mIU/L at Screening]. Hypothyroidism treated with the same dose and regimen of thyroid hormone replacement for at least 3 months prior to Screening is allowed.
- •BMI of <25 or >40 kg/m2.
- •Significant weight gain or loss (as defined as >5% of total body weight) in the 3
- •months prior to Screening.
- •2. Diabetic Medication
- •Has taken insulin for more than 2 weeks in the 12 months prior to screening or
- •at any time within the 3 months prior to screening.
- •Has taken any oral anti-diabetic medication for more than 4 weeks in the 12
- •months prior to screening or at anytime within the 3 months prior to screening.
- •3. Cardiovascular Disease
- •Recent history or presence of clinically significant acute cardiovascular disease
- •- Documented myocardial infarction in the 6 months prior to Screening.
- •- Coronary revascularization including percutaneous transluminal coronary
- •angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery either
- •planned and/or occurred in the 6 months prior to Screening.
- •- Unstable angina in the 6 months prior to Screening.
- •- Clinically significant supraventricular arrhythmias requiring medical therapy,
- •or history of nonsustained or sustained ventricular tachycardia. Symptomatic
- •valvular heart disease or valvular heart disease requiring therapy other than
- •endocarditis prophylaxis.
- •- Congestive heart failure (CHF, New York Heart Association (NYHA) Class II
- •to IV) requiring pharmacologic treatment. NYHA Class I may be included in
- •accordance with the local prescribing information for pioglitazone.
- •- Blood pressure (BP) >150/100mmHg. If a subject is receiving permitted
- •antihypertensive therapy, then they must be on stable dose(s) of therapy for at
- •least 3 month prior to Screening.
- •- Has a QTc interval (Bazett’s) =450msec at Screening on a single ECG or an
- •average value from 3 ECGs taken 5 minutes apart (on local reading of ECG).
- •- Other clinically significant ECG abnormalities which, in the opinion of the
- •investigator, may affect the interpretation of efficacy and safety data, or which
- •otherwise contraindicates participation in a clinical trial with a new chemical
- •Fasting plasma triglycerides =400mg/dL (4.56mmol/L) at Screening. If a
- •subject is receiving permitted lipid-lowering therapy, then they must be on a
- •stable dose(s) of therapy for at least 3 months prior to Screening. Niacin and
- •bile acid sequestrants are prohibited.
- •4. Hepatic Disease
- •Has a diagnosis of active hepatitis (hepatitis B surface antigen or hepatitis C
- •antibody), or clinically significant hepatic enzyme elevation including:
- •Any one of the following enzymes greater than 2 times the upper limit of the
- •reference range (ULRR) value at Screening.
- •- alanine transaminase (ALT).
- •- aspartate transaminase (AST).
- •- alkaline phosphatase (AP).
- •Has a total bilirubin level that is >1.5 times the ULRR at Screening with the
- •exception of suspected or confirmed Gilbert’s disease.
- •5. Pancreatic Disease
- 另有 5 项未显示
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