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临床试验/PER-038-08
PER-038-08已完成未知

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SITAGLIPTINE AGAINST GLIPIZIDE IN PATIENTS WITH DIABETES MELLITUS TYPE 2 AND TERMINAL PHASE NEPHROPATHY THAT ARE SUBJECTED TO DIALYSIS AND HAVE AN INAPPROPRIATE GLYCEMIC CONTRO

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2008年6月9日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
发起方
研究概览入排标准研究者记录与标识符相似试验

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

年龄范围
30 至 100（—）

入选标准

  • •The patient suffers from type 2 diabetes mellitus (T2DM).
  • •The patient is receiving dialysis (hemodialysis or peritoneal dialysis for at least 6 months) on the day of signing the informed consent.
  • •The patient is> 30 years old on the day of signing the informed consent.
  • •The patient is male.
  • •The patient is a woman sterilized by surgical means.
  • •The patient is a postmenopausal woman> 45 years old with> 2 years since her last menstruation.
  • •The patient is a premenopausal woman, not sterilized and who accepts to abstain from the practice of heterosexual activity or is willing to use an adequate contraceptive method.
  • •The patient understands the study procedures, available alternative treatments and risks involved with the study and voluntarily agrees to participate by providing written informed consent.
  • •The patient is likely to complete the study.
  • •The patient meets one of the following criteria, as indicated by an affirmative response to it:
  • •The patient is not currently in therapy with antihyperglycaemic agents (without therapy for> 12 weeks) and has at Visit 1 an HbA1c> 7% and <9%. The patient is in one of the following 2 categories and according to the review of the current diet, the patient´s medical regime and HbA1c at Visit 1, the researcher considers that the patient possibly meets the inclusion criteria of Visit 4 / Week -2 of HbA1c> 7% and <9%;
  • •The patient is not currently in therapy with antihyperglycemic agents (without therapy> 12 weeks) and has an HbA1c> 9% at Visit 1 and after a period of diet and exercise, is likely to have an HbA1c> 7% and <9% at two weeks or within two weeks prior to Visit 4 / Week -2.
  • •The patient is currently on monotherapy with antihyperglycemic agents (or low dose oral combination therapy [ie <50% of the maximum tolerated dose of each agent]) and has an HbA1c> 6% and <9% in the Visit 1
  • •HbA1c> 7% and <9% measured on or within 2 weeks before Visit 4 / Week -2.
  • •The patient has a compliance of> 85% of the study drug during the simple blind placebo transition period (according to the tablet / capsule count).
  • •The patient complies with the diet, exercises and other transition treatments during the transition period.

排除标准

  • •The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
  • •The patient is in a weight loss program and is not in the maintenance phase (defined as a weight loss of <2 kg in 2 months).
  • •The patient intends to participate in a weight reduction intervention not prescribed in the study.
  • •The patient is, at the time of signing the informed consent, a user of recreational or illicit drugs or has presented a recent history (within the last year) of drug or alcohol abuse or dependence.
  • •The patient has a clinically important hematologic disorder (eg, aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
  • •The patient has cirrhosis or an active liver disease (other than fatty liver), a chronic progressive neuromuscular disorder (for example, multiple sclerosis or polymyositis) or has any other condition or therapy that, in the opinion of the researcher or medical monitor of Merck, could put the patient at risk or make the patient´s participation not what is best for him.
  • •The patient has undergone dialysis for <6 months.
  • •The patient does not regularly comply with the prescription on dialysis.
  • •The patient has been diagnosed with a significant cardiovascular disorder (eg, MI or unstable angina) or has undergone a cardiovascular procedure (eg, CABG or PTCA) within 3 months of signing the informed consent.
  • •The patient presents with new or worsening signs or symptoms of congestive heart failure within 3 months of signing the informed consent (See Appendix 6.6.).
  • •The patient has an active peripheral vascular disease (for example, manifested by claudication with normal activity, an ischemic ulcer that does not heal or a disease that probably requires an intervention such as a bypass or angioplasty).
  • •The patient presents a recent diagnosis / episode / recurrence (within 3 months prior to signing the informed consent) of stroke, TIA, or neurological disorder, including, but not limited to, seizures, fainting, or a recent change within of the 3 months prior to signing the informed consent) in the dose or class of drugs used to treat these conditions.
  • •The patient has a history of malignancy <5 years before signing the informed consent, or> 5 years without information about remission / cure.
  • •The patient has undergone a surgical procedure within 1 month prior to signing the informed consent or plans to undergo major surgery.
  • •In patient is under treatment for hyperthyroidism.
  • •The patient is pregnant, has a pregnancy test with a positive result in Visit 1, expects to conceive within the projected duration of the study or is breastfeeding.
  • •The patient hopes to donate eggs within the projected duration of the study.
  • •The patient has been diagnosed with HIV (according to the medical history evaluation).
  • •The patient has a current history or evidence of any condition, therapy, laboratory abnormality or other circumstance that, in the opinion of the researcher or Merck´s medical monitor, may pose a risk to the patient or cause the patient´s involvement not to be the most convenient, that could confuse the results of the study or interfere with the participation of the patient throughout the study.
  • •The patient is unlikely to comply with study procedures, keep appointments or plan to move during the study.
  • •The patient currently uses, has used within 3 months prior to signing the informed consent

研究者

发起方
MERCK SHARP & DOHME PERU S.R.L.,

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