EUCTR2005-002907-18-HU进行中（未招募）不适用
A multi-center phase 2 randomized, double-blind, placebo-controlled dose-ranging study to determine the efficacy, safety, tolerability and pharmacokinetics of RO4389620 in patients with type 2 diabetes mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •- Age 30 to 75 years at the time of the screening examination
- •- A medical history of type 2 diabetes mellitus as defined by World Health Organization for longer than 3 months prior to screening
- •- Male and female patients either treatment naïve inadequately controlled despite diet and exercise or inadequately controlled patients on monotherapy or on combination therapy (max. 2 oral antihyperglycemic medications)
- •- HbA1c = 10.0 % at screening and HbA1c more or equal than 7.0 % and = 10.0 % at pre-randomization visit
- •- FPG > 126 mg/dL (7.0 mmol/L) and = 240 mg/dL (13.3 mmol/L) at pre-randomization visit
- •- BMI = 45 kg/m2 at screening
- •- Patients able and willing to give written informed consent and to comply with the requirements of the study
- •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
- •- Type 1 diabetes mellitus patients
- •- Any severe hypoglycemic episode within the last 3 months (requiring assistance by another person to recover)
- •- Frequent (more than 3-4 episodes per week) moderate hypoglycemic episodes
- •- History of ketoacidosis
- •- Type 2 diabetes mellitus patients treated with insulin or PPAR? (e.g. Actos®, Avandia®, Avandamet®) during the last 3 months
- •- Any antidiabetic drug not stopped at start of wash-out/placebo run-in period
- •- Treatement with strong CYP450 3A4 inducers (such as rifampicin), or potent CYP450 3A4 inhibitors (such as atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole)
- •- Systemic use of corticosteroids in the last 3 months
- •- Impaired liver function (ALAT, ASAT, total and direct bilirubin or alkaline phosphatase > 2.5x ULN) at screening or pre-randomization examination
- •- Severely impaired kidney function (creatinine clearance < 30 mL/min/1.73 m2) at screening or pre-randomization examination
- •- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg, despite treatment) at the time of the screening examination
- •- Myocardial infarction or stroke within 6 months prior to the screening examination
- •- Known proliferative diabetic retinopathy
- •- Any abnormality in clinical laboratory tests or ECG, which precludes safe involvement in the study as judged by the investigator.
- •- Body weight change between screening and pre-randomization more or equal than +/- 10 %
- •- Pregnant or lactating women
- •- Female patients of childbearing potential who with their partners refuse to use two forms of contraception (including 1 barrier method) from screening and for one month following the last study drug intake
- •- Participation in an investigational drug study within 90 days (3 months) prior to screening
- •- Serious illness, such as active cancer, major active infection, severe psychiatric disorders at the time of the screening examination
- •- Alcohol or drug abuse
研究者
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