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临床试验/PER-063-06
PER-063-06已完成未知

A PHASE III, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO STUDY THE SAFETY AND EFFECTIVENESS OF THE ADDITION OF SITAGLIPTIN (MK-0431) IN PATIENTS WITH DIABETES MELLITUS TYPE 2 WHO HAVE IMPROPER GLYCEMIC CONTROL WITH COMBINATION THERAPY WITH METFORMIN AND AN AGONIST FROM PPAR

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2006年9月19日最近更新:
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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
0 至 0（—）

入选标准

  • •a) The patient suffers from diabetes mellitus type 2 (T2DM).
  • •b) The patient is a man or woman and is ≥ 18 and ≤ 78 years of age on the day he signs the consent.
  • •c) The patient understands the study procedures, alternative treatments available and the risks involved in the study and voluntarily accepts to participate in the study.
  • •d) The patient is male, or a woman whose chances of conceiving are very improbable: 1) The patient is male. 2) The patient is a woman surgically sterilized. 3) The patient is a post-menopausal woman ≥ 45 years of age whose last menstruation occurred> 2 years ago. 4) The patient is a non-sterilized pre-menopausal woman who agrees to: (1) use 2 adequate contraceptive methods to prevent pregnancy OR (2) abstain from having heterosexual relationships throughout the study, starting with the Screening Visit and during 14 days after taking the last dose of the study drug.
  • •e) The patient currently receives stable doses of dual AHA therapy.
  • •f) The patient has a body mass index (BMI)> 20 kg / m2 and <43 kg / m2.

排除标准

  • •a) The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
  • •b) The patient required insulin within the previous 3 months.
  • •c) The patient has been taking Byetta® (exenatide) within the previous 3 months.
  • •d) The patient is following a weight reduction program and is not in the maintenance phase or has started a treatment with a weight loss drug within the previous two months.
  • •e) The patient is receiving or is likely to require treatment with immunosuppressive / immunomodulatory agents during the study or the patient is receiving or is likely to require treatment for ≥ 14 consecutive days or repeated courses of pharmacological doses of corticosteroids.
  • •f) The patient has undergone surgery within the previous 30 days or has scheduled major surgery.
  • •g) The patient has received treatment with an investigational drug within the previous 3 weeks or is participating in a clinical trial.
  • •h) The patient has been previously treated with sitagliptin (MK-0431).
  • •i) The patient has a history of hypersensitivity or intolerance to the use of metformin or a PPARy agonist.
  • •j) The patient presents new signs or symptoms of coronary heart disease or the worsening thereof within the last 3 months or suffers from any of the following disorders within the last 6 months: • Acute coronary syndrome. • Coronary artery intervention. • Stroke or transient ischemic neurological disorder.
  • •k) The patient has a severe peripheral vascular disease.
  • •l) The patient suffers from congestive heart failure requiring pharmacological therapy or NYHA Class II, III or IV congestive heart failure.
  • •m) The patient is pregnant or nursing or expects to conceive within the projected duration of the study.
  • •n) The patient expects to donate their eggs within the projected duration of the study.
  • •o) The patient is HIV positive.
  • •p) The patient suffers from viral hepatitis.
  • •q) The patient has a clinically important hematologic disorder.

研究者

发起方
MERCK SHARP & DOHME PERU S.R.L.,

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