EUCTR2004-000540-24-GB进行中（未招募）不适用
A multicenter, double-blind, randomized, active controlled study to compare the effect of long term treatment with LAF237 50 mg bid to gliclazide up to 320 mg daily in drug naïve patients with type 2 diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,120
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
- •1.Male, non-fertile female (i.e., post menopausal, post hysterectomy, or sterilized by tubal ligation) or female of childbearing potential using a medically approved birth control method (e.g., hormonal contraceptives, IUD, double-barrier contraception). A female of childbearing potential using a medically approved birth control method must be willing to use the same method of contraception during the full course of the study.
- •2.Drug naïve patients with type 2 diabetes (drug naïve patients are defined as patients who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for > 3 consecutive months).
- •3.Age = 18 years.
- •4.Body mass index (BMI) in the range of 22-45 kg/m2 inclusive at visit 1.
- •5.HbA1c in the range of 7.5% to 11% inclusive at visit 1.
- •6.FPG less than 15 mmol/L (270 mg/dL) at visit 1.
- •7.Agreement to maintain prior diet and exercise habits during the full course of the study.
- •8.Written informed consent to participate in the study.
- •9.Ability to comply with all study requirements.
- •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
- •1.Pregnant or lactating female.
- •2.A history of:
- •type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly.
- •acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
- •3.Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
- •4.Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
- •5.A history of:
- •Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
- •percutaneous coronary intervention within the past 3 months.
- •any of the following within the past 6 months: myocardial infarction (MI) (If the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor); coronary artery bypass surgery; unstable angina; or stroke.
- •6.Congestive heart failure NYHA class III or IV.
- •7.Any of the following ECG abnormalities:
- •second degree AV block (Mobitz 1 and 2)
- •third degree AV block
- •prolonged QTc (> 500 ms)
- •8.Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
- •9.Liver disease such as cirrhosis or chronic active hepatitis.
- •10.Acromegaly or treatment with growth hormone or similar drugs.
- •11.Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- •12.Donation of one unit (500 mL) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
- •13.Contraindications and warnings according to the country specific label for gliclazide not listed in the other exclusion criteria.
- •14.Known sensitivity to gliclazide or other sulfur containing drugs.
- •15.Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months.
- •16.Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
- •17.Treatment with class Ia, Ib and Ic or III anti-arrhythmics.
- •18.Thyroid hormone replacement is allowed if the dosage has been stable for at least 3 months and the TSH is within normal limits at visit 1.
- •19.Investigational drug treatment within 4 weeks prior to visit 1 unless local health authority guidelines mandate a longer period.
- •20.Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (i.e., cytostatic drugs).
- •21.Any of the following significant laboratory abnormalities:
- •ALT, AST greater than 3 times the upper limit of the normal range at visit 1.
- •Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 1.
- •Serum creatinine levels = 220 ?mol/L (2.5 mg/dl) at visit 1.
- •TSH outside of normal range at visit 1.
- •Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1.
- •Fasting triglycerides (> 7.9 mmol/L (>700 mg/dL) at visit 1.
- •22.History of substance abuse (including alcohol) within the past 2 years.
- •23.Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
研究者
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