PER-089-04已完成未知
MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE SAFETY OF THE MONOTHERAPY WITH MK-0431 IN PATIENTS WITH DIABETES MELLITUS TYPE 2 AND CHRONIC RENAL INSUFICIENCY THAT HAVE AN INAPPROPRIATE GLUCEMIC CONTROL.
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2005年1月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •The patient has type 2 diabetes mellitus.
- •The patient has moderate, severe or terminal renal insufficiency, as indicated by a yes response to one or more of the following statements: 1) Creatinine clearance> 30 to <50 ml / min 2) Creatinine clearance < 30 mL / min 3) The patient is dialyzed
- •The patient is> 18 years of age.
- •The patient understands the study procedures and agrees to participate in it by providing written informed consent
- •The patient is not pregnant or nursing and does not plan to become pregnant during the course of the study and the post-study follow-up period.
- •The patient is a man, or a woman who is highly unlikely to conceive, as indicated by, at least, a yes answer to the following questions: 1) The patient is a man 2) The patient is a surgically sterilized woman 3) The patient is a post-menopausal woman> 45 years of age who has stopped menstruating> 2 years 4) The patient is an unsterile pre-menopausal woman who agrees to use 2 contraceptive methods adequate barrier to prevent pregnancy or agree to abstain from having heterosexual intercourse during the study from Visit 1 and for 14 days after the last dose of the study medication (Refer to Section LE 11.a. for a description of accepted contraceptive methods).
- •The patient meets one of the following criteria as indicated by a yes response: 1) The patient is not currently receiving an antihyperglycemic agent (out of therapy for> 8 weeks), and has an HbA1c> 6.5% and <10% at the Screening Visit OR The patient is in 1 of the following 2 categories and based on the review of their current diet, medical regimen and HbA1c at Visit 1 / Screening Visit, the researcher considers that it is the patient is likely to meet the inclusion criteria of HbA1c ^ 6.5% to <10% at Visit 3 with advice on diet / exercises: 2) The patient is not currently receiving an antihyperglycemic agent and has an HbA1c> 10% at the Screening Visit 3) The patient is currently receiving monotherapy with an antihyperglycemic agent (or low dose oral combination therapy [ie, <50% of the maximum dose indicated on the label of each agent]) and have an HbA1c ^ 6% and <10% in the Selection Visit.
- •The patient has an estimated creatinine clearance (using the Cockcroft-Gault formula) <50 ml / min and is generally stable with respect to the value of Visit 1, defined as 80-120% with respect to the measurement of the Visit 1. Note: If the researcher evaluates that the value of Visit 3 does not reflect the current status of the patient, a single repetition of the measurement can be carried out, at the discretion of the investigator. If the repeated value meets the criteria for inclusion of the creatinine clearance of Visit 3, the patient can continue in the study.
- •HbA1c is> 6.5% and <10% according to the measurement made in Visit 3 or during the 2 weeks prior to that visit.
- •Patient has compliance> 75% (as measured by tablet count) with respect to placebo treatment during transition
排除标准
- •The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
- •The patient required insulin within the previous 8 weeks.
- •The patient is following a weight loss program and is not in the maintenance phase.
- •The patient began taking a medicine to lose weight (for example, orlistat or sibutramine) within the previous 8 weeks.
- •The patient is receiving or is likely to require pharmacological doses of corticosteroids for> 14 consecutive days or during repeated cycles.
- •The patient is taking an excluded medication as indicated by a s1 response to one of the following statements: 1) The patient is taking an immunosuppressive / immunomodulatory agent (eg, cyclosporine, methotrexate, etanercept) 2) The patient you are taking digoxin or another cardiac glycoside.
- •The patient has undergone surgery that required general anesthesia within the previous 30 days or the patient has a scheduled surgery. Note: Patients who have a scheduled minor surgery can enroll after approval of the Merck medical monitor.
- •The patient has received treatment with an investigational drug within the previous 8 weeks.
- •The patient has an acute or rapidly progressive nephropathy, or has a history of kidney transplantation.
- •The patient has an ALT or AST> 2.0 times the upper limit of normal (ULN).
- •The patient has a level of triglycerides (TG)> 600 mg / dL (6.78 mmol / L) and the researcher considers that it is unlikely that he will respond to the diet / exercises and / or medication to avoid exceeding the level of TG> 600 mg / dL (6.78 mmol / L) at Visit 3.
- •The patient has a TSH <0.100 pU / mL or> 15 pU / mL.
- •The patient has a TSH> 6 pU / mL but <15 pU / mL and does not wish, or is not considered appropriate, to initiate / adjust a thyroid hormone replacement therapy, in such a way that the patient avoids exceeding the TSH> 6 pU / mL at Visit 3 / Week -2. Note: If thyroid hormone replacement therapy is initiated or adjusted due to a TSH level> 6 pU / mL but <15 pU / mL, the dose of thyroid hormone replacement therapy should remain stable for a minimum of 5 weeks. weeks before its repetition in Visit 3 / Week -2.
- •The patient suffers from cirrhosis, active liver disease (different from fatty liver), or symptomatic active cholecystopathy.
- •The patient suffers from chronic myopathy, or a progressive neuromuscular or neuromuscular disorder (eg, multiple sclerosis or polymyositis).
- •The patient has one of the following disorders in the last 6 months: • Acute coronary syndrome (for example, MI or unstable angina). • Coronary artery surgery (for example, CABG or PICA). • Worsening of congestive heart failure (eg, worsening of symptoms or increase in drug therapy). • Stroke or transient ischemic neurological disorder.
- •The patient presents new signs or symptoms of coronary heart disease, or worsening thereof, in the last 3 months.
- •The patient suffers from a severe peripheral vascular disease (for example, manifested by claudication with minimal activity, ischemic ulcer that does not heal, or disease that probably requires surgery, such as a bypass or angioplasty).
- •The patient is HIV positive (according to the medical history evaluation).
- •The patient has a clinically important hematologic disorder (for example, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia). Note: Patients suffering from chronic and stable anemia, in
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