Multicenter, double-blind, randomized, placebo controlled, dose ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of the DPP-IV inhibitor RO0730699 in patients with type 2 diabetes, who are treated with a stable dose of metformin

F. Hoffmann-La Roche Ltd0 个研究点目标入组 200 人开始时间: 2005年1月28日最近更新: 2012年3月19日

试验速览

暂无简介。

•- Type 2 diabetes treated with the maximum tolerated dose of metformin (minimum 1500 mg daily dose, maximum not higher than recommended in the label) for at least 3 months before screening
•- HbA1c > or equal 7.0% and < or equal 10.0% at screening
•- FPG at screening
•> 126 mg/dL (7.0 mmol/L) and
•< or equal 240 mg/dL (13.3 mmol/L)
•- BMI < or equal 40 kg/m2
•- Age 18 to 75 years
•- 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

•-Type 1 diabetes
•- History of ketoacidosis or lactic acidosis
•- Any anti-hyperglycemic medication other than metformin during the last 3 months (combination therapy)
•- Use of systemic corticosteroids during the last 3 months
•- History of convulsions and/or epilepsy
•- Central nervous system disease with potential impact on the blood brain barrier, ie. history of stroke, Alzheimer’s disease, cerebrovascular dementia.
•- Impaired liver function (ALAT, ASAT, total bilirubin or alkaline phosphatase >2.5 x ULN) at screening
•- Contraindications to metformin, i.e.
•* Impaired renal function (serum creatinine > 1.5 mg/dL [ > 133 micromol/L] in males and >1.3 mg/dL [>115micromol/L] in females)
•* Congestive heart failure requiring pharmacologic treatment
•* Respiratory insufficiency
•- Myocardial infarction < 6 months before screening
•- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg despite treatment)
•- Known proliferative diabetic retinopathy
•- Serious illness, such as active cancer, major active infection, severe psychiatric disorders
•- Pregnant or lactating women or women with childbearing potential not using adequate method of contraception
•- Participation in a clinical trial with an investigational drug within 3 months prior to the screening examination

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