EUCTR2006-003897-87-GB进行中（未招募）不适用
A 24-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE SAFETY AND EFFICACY OF PPM-204 IN SUBJECTS WITH TYPE 2 DIABETES.
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development0 个研究点目标入组 500 人开始时间: 2006年12月17日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- •Inclusion Criteria at Screening (Week -3)
- •1. Type 2 diabetic men and women of non-childbearing potential, 18 to 70 years old.
- •- Women of non-childbearing potential may be included if they are surgically sterile (hysterectomy and/or oophorectomy) or postmenoausal (at least 12 months of spontaneous amenorrhea). If the menopausal status is uncertain, a FSH level > 38 mIU/mL will allow enrollment. Surgical sterility must be documented in the subject’s source documents prior to randomization.
- •2. Subjects currently treated with diet and exercise alone, and subjects receiving a single oral antidiabetic medication.
- •3. BMI > 23 and < 43.
- •4. HbA1c at screening (week –3)·
- •- for subjects currently treated with 1 antidiabetic medication: HbA1c >or= 7.2% and
- •- for subjects not currently treated with antidiabetic medications: HbA1c >or= 7.2% and
- •5. Willingness to comply with the prescribed weight maintenance diet and physical exercise regimen.
- •6. Participation in a drug investigational trial within 30 days before screening visit (Week-3 visit).
- •Inclusion Criteria at Week -1; All subjects:
- •1 HbA1c < or = to 9.0 %.
- •- The value of HbA1c at week -1 will be used to determine the subject’s eligibility for the treatment period.
- •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
- •Exclusion Criteria at Screening (Week -3):
- •1. Subjects requiring insulin therapy.
- •2. Subjects currently receiving 2 or more oral antidiabetic medications; subjects receiving an oral antidiabetic medication are required to discontinue the treatment at screening.
- •3. Subjects currently receiving thiazolidinediones. Subjects previously treated with thiazolidinediones may enroll if they discontinued treatment at least 8 weeks before the screening visit.
- •4. Subjects requiring systemic corticosteroids (however, topical, inhaled or nasal corticosteroids are acceptable). Subjects previously treated with systemic corticosteroids may enroll if they discontinue treatment at least 4 weeks before the screening visit.
- •5. Subjects receiving warfarin.
- •6. Significant diabetic complications (proliferative retinopathy or history of macular edema), nephropathy (defined by e-GFR
- •7. Aspartate transaminase (AST), alanine transaminase (ALT) or alkaline phosphatase >or= 3.0 times upper limit of normal (ULN).
- •8. Total bilirubin >or= 1.5 mg/dL (>or= 26 mmol/L), unless the elevation is due to Gilbert’s disease.
- •9. Estimated GFR
- •10. Total fasting triglycerides > 500 mg/dL [5.6 mmol/L].
- •11. TSH or =9.0 mIU/mL.
- •12. Hemoglobin < 10.0 g/dL (100.0 g/L).
- •13. Uncontrolled hypertension, i.e., systolic BP > 160 mmHg; diastolic BP >110 mmHg, treated or untreated.
- •14. History of heart failure: NYHA Class 3 and 4 are excluded.
- •15. History or clinical manifestation of significant central nervous system, hematological, metabolic, pulmonary, cardiovascular (within 6 months: angioplasty, stroke, myocardial infarction or CABG), gastrointestinal, endocrine (except type 2 diabetes), renal or hepatic disorder.
- •16. HIV infection as determined in the medical history.
- •17. Positive serologic findings hepatitis B surface antigen, and/or hepatitis C virus antibodies.
- •18. Evidence of clinically significant infection.
- •19. Known or suspected drug or alcohol abuse within the past year.
- •20. Psychiatric or emotional disorders that might prevent the successful completion of the study.
- •21. Surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the test article.
- •22. History of malignancy within 5 years of enrollment into the study (with the exception of adequately treated basal cell carcinoma of the skin).
- •Exclusion Criteria at Week -1:
- •1 Evidence of clinically significant infection.
- •2. Acute disease state (e.g., nausea, vomiting, fever, diarrhea) within 7 days before Day 1.
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