PER-111-06已完成未知
A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone or Pioglitazone HCl Alone in Subjects With Type 2 Diabetes
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试验速览
研究概览
简要总结
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研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •1. Men and women, between 18 and 80 years of age with a historical diagnosis of type 2 diabetes.
- •2. Treatment with diet and exercise of the subject has failed, at least 2 months prior to the Evaluation for Selection.
- •3. The subject experiences inadequate glycemic control, defined as HbA1c concentrations between 7.5-11%.
- •4. The subject has received less than 7 days of any antidiabetic therapy within 3 months prior to the Evaluation for Selection.
- •5. The subject is able to understand and meet the requirements of the protocol.
- •6. The subject or the legal representative of the subject signs a written informed consent form before initiating any of the study procedures.
- •7. The subject has a Body Mass Index ≥ 23 kg / m2 and ≤ 45 kg / m2.
- •8. The subject has a fasting C-peptide ≥ 0.8 ng / mL (0.26 nmol / L).
- •9. The subject who has regularly used other medications not excluded, must be with a stable dose at least 4 weeks before the Evaluation for Selection.
- •10. Women of childbearing age should use an adequate contraceptive method from the Evaluation for Selection and throughout the study.
- •11. The subject is not pregnant or nursing.
- •12. The subject should be able and willing to monitor their blood concentrations with a glucose monitor at home.
排除标准
- •1. The subject has a systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg.
- •2. The subject has hemoglobin ≤ 12 g / dL for men and ≤ 10 g / dL for women.
- •3. Subject has alanine aminotransferase (ALT)> 2.5x upper normal limit.
- •4. Subject has serum creatinine> 2.0 mg / dL.
- •5. The subject has a level of thyroid stimulating hormone> at the upper limit of normal.
- •6. The subject has a major illness or weakness that prevents the subject from completing the study.
- •7. The subject has a urine albumin / creatinine ratio> 1000 pg / mg in the evaluation for the Selection.
- •8. The subject has a history of cancer.
- •9. The subject has a history of laser treatment for proliferative diabetic retinopathy within 6 months prior to the evaluation for the Selection.
- •10. The subject has a history of gastroparesis.
- •11. The subject has heart failure classified as class III or IV.
- •12. Subject has a history of coronary angioplasty, coronary stenting, coronary bypass surgery, or myocardial infarction within 6 months prior to screening.
- •13. The subject has a history of any type of hemoglobinopathy that could affect the determination of HbA1c.
- •14. The subject has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
- •15. The subject has a history of psychiatric disorders that will affect their availability to participate in the study.
- •16. The subject has a history of angioedema related to the use of angiotensin-converting enzyme inhibitors or angiotensin II receptor inhibitors.
- •17. The subject has had any alteration of angiotensin II receptor inhibitors during the 2 months prior to randomization.
- •18. The subject has a history of alcohol abuse or substance abuse within 2 years prior to the Screening Evaluation.
- •19. The subject has received any investigational medication within 30 days prior to the evaluation for the selection or history of having received an anti-diabetic medication under investigation during the 3 months prior to the Screening Evaluation.
- •20. The subject has previously participated in a research study of SYR-322.
- •21. Subject is unable to understand oral or written English or any other language for which a certified translation of the approved informed consent is available.
研究者
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