EUCTR2006-006273-25-FR进行中（未招募）1 期
A multi-center, double-blind, randomized, placebo-controlled, titration study to investigate the safety, the tolerability and the pharmacodynamic profiles of different doses of RO5073031 in patients with type 2 diabetes mellitus treated with a stable dose of metformin.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 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
- •- Able and willing to give written informed consent and to comply with the requirements of the study protocol (patients must be able to perform self-monitoring of blood glucose and/or comply with protocol requirements independently from another person to be included in the study).
- •- Type 2 diabetes mellitus patients treated with stable metformin monotherapy (at any dose, but not higher than recommended in the label) for at least 3 months prior to screening.
- •- Age 18 to 75 years at the time of screening.
- •- HbA1c = 7.0 % and = 9.5 % at screening.
- •- Fasting plasma glucose (FPG) > 126 mg/dL (7.0 mmol/L) and = 240 mg/dL (13.3 mmol/L) at screening.
- •- BMI > 25 kg/m2 and = 45 kg/m2 at screening.
- •- Stable weight ± 10% for at least 3 months before screening.
- •- If receiving ACE inhibitors, angiotensin II antagonists, beta blockers, thiazide diuretics, thyroid hormones and/or lipid lowering medications, the dose(s) must have been stable for at least 6 weeks prior to screening.
- •- Males, postmenopausal women (defined as more than one year after the cessation of menses and documented by FSH > 50 UI/L) or surgically sterilized women (by means of hysterectomy, bilateral oopherectomies or tubal ligations).
- •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
- •- Known hypersensitivity to RO5073031 or any of the components of its formulation.
- •- Type 1 diabetes mellitus patients.
- •- Clinically significant GI disease including inflammatory bowel disease, irritable bowel syndrome, celiac disease, dyspepsia, apparent diabetic gastroparesis, diabetic diarrhea or surgery of the gastrointestinal tract (except appendicectomy/cholecystectomy).
- •- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg, despite treatment) at the time of screening.
- •- Myocardial infarction or stroke within 6 months prior to screening.
- •- Known proliferative diabetic retinopathy.
- •- Known haemoglobinopathy or chronic anemias.
- •- Evidence of serious concomitant disease, such as active cancer, major active infection or severe psychiatric disorders, at the time of screening.
- •- Any new conditions diagnosed at screening requiring treatment longer than 10 days or chronic therapies that can not be stabilized during the screening period.
- •- Contraindications to metformin, i.e.
- •- Congestive heart failure requiring pharmacologic treatment
- •- Clinically significant respiratory insufficiency.
- •- History of ketoacidosis or lactic acidosis.
- •- Any previous exposure to GLP-1, GLP-1 analogues or exenatide.
- •- Treatment with any anti-hyperglycemic medication other than metformin monotherapy within 3 months prior to screening (except insulin use for up to 7 days in acute situations).
- •- Systemic (oral or parental) use of corticosteroids within 6 weeks prior to screening.
- •- Use of weight lowering medications (orlistat, sibutramine, rimonabant, phentermine) within 3 months prior to screening.
- •- Impaired liver function (ALT, AST, total bilirubin or alkaline phosphatase > 2.5x ULN) at screening.
- •- Renal disease or renal dysfunction (as suggested by serum creatinine levels = 1.5 mg/dL (133 umol/L) [males], =1.4 mg/dL (124 umol/L) [females]) at screening.
- •- Any abnormalities in clinical laboratory tests or ECG, which preclude safe involvement in the study as judged by the Investigator.
- •- Participation in an investigational drug study within 90 days (or five half-lives, whichever is longer) prior to screening.
- •- Pregnant women, lactating women or women of childbearing potential.
- •- Alcohol or drug abuse.
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