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临床试验/EUCTR2006-002354-30-DE
EUCTR2006-002354-30-DE进行中(未招募)不适用

Effect of Acute Insulin Intervention followed by Pioglitazone and Metformin Treatment on Metabolic Parameters in Type 2 Diabetic Patients with inadequate Metabolic Control

Takeda Pharma GmbH0 个研究点开始时间: 2006年6月8日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • 1.Type 2 diabetes according to the ADA Criteria
  • 2.Treatment with oral antidiabetic agents except PPAR?- agonists
  • 3.Age 30-75 years
  • 4.Fasting C-Peptide levels > 2 ng/mL
  • 5.HbA1c >= 6.5%
  • 6.more than 2 blood glucose measurements >200 mg/dL within the last two weeks
  • 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

  • 1.Type 1 diabetes mellitus
  • 2.History of ketoacidosis or lactic acidosis
  • 3.Use of systemic corticosteroids within the last 3 months prior to screening visit
  • 4.Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
  • 5.History of severe or multiple allergies
  • 6.Treatment with any other investigational drug within 3 months before trial entry.
  • 7.Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypo¬glycaemia) within 6 months prior to screening visit
  • 8.Progressive fatal disease
  • 9.History of drug or alcohol abuse within the last 5 years prior to study participation
  • 10.A history of significant cardiovascular ( NYHA stage II - IV), respiratory, gastrointestinal, hepatic (ALAT > 2.5 times the normal reference range), renal (creatinine > 1.1 mg/dL in women and > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator.
  • 11.Blood donation within the last 30 days
  • 12.Pregnancy or breast feeding
  • 13.Sexually active women of childbearing age not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner.
  • 14.Lack of compliance or other similar reason, that, the investigator believes, precludes satisfactory participation in the study
  • 15.Pre-treatment with PPAR? agonists within the 3 months prior to screening
  • 16.Respiratory insufficiency
  • 17.Myocardial infarction within 6 months prior to screening visit

研究者

发起方
Takeda Pharma GmbH

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