EUCTR2004-004528-11-LV进行中（未招募）不适用
Multicenter, double-blind, randomized, placebo-controlled, dose ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of the DPPIV inhibitor RO0730699 in patients with type 2 diabetes - NA
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
- •- Type 2 diabetes diagnosed at least 1 month before screening and either drug naïve or pre-treated with monotherapy or combination therapy (max. two oral antihyperglycemic medications, not on maximum dose)
- •< or equal 10.0% at screening
- •> or equal 7.0% and < or equal 10.0% at pre-randomization visit
- •- FPG at pre-randomization visit
- •> 7.0 mmol/L (126 mg/dL) and
- •< or equal 13.3 mmol/L (240 mg/dL)
- •- BMI < or equal 40 kg/m2 at screening
- •- Age 18 to 75 years at screening
- •- 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
- •- Type 2 diabetes treated with insulin or a PPAR? agonist (e.g. Actos ®, Avandia ®, Avandamet ®) during the 3 months before screening
- •- History of ketoacidosis
- •- Any antihyperglycemic medication not stopped at start of wash-out/placebo run-in period
- •- Use of systemic corticosteroids during the 3 months before screening
- •- History of convulsions and/or epilepsy
- •- CNS disease with potential impact on the blood-brain barrier (e.g. history of stroke, Alzheimer`s disease, cerebrovascular dementia)
- •- Impaired liver function (ALAT, ASAT, total bilirubin or alkaline phosphatase >2.5 x ULN) at screening
- •- Impaired renal function (serum creatinine > or equal 177 micromol/L [> or equal2.0 mg/dL]) at screening
- •- Myocardial infarction < 6 months before screening
- •- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg despite treatment) at screening
- •- Known proliferative diabetic retinopathy
- •- Serious illness, e.g. active cancer, major active infection, or severe psychiatric disorders at the time of the screening examination
- •- Positive pregnancy test, lactating women or women with childbearing potential unless using reliable contraception
- •- Participation in a clinical trial with an investigational drug within 3 months prior to the screening examination
研究者
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