A 24-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE SAFETY AND EFFICACY OF PPM-204 IN SUBJECTS WITH TYPE 2 DIABETES - ND

Wyeth Research Division of Wyeth Pharmaceutical Inc., Clinical Research and Development0 个研究点目标入组 500 人开始时间: 2007年4月27日最近更新: 2012年3月19日

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•?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.?Subjects currently treated with diet and exercise alone and subjects receiving a single oral antidiabetic medication ?BMI > 23 and < 43 ? HbA1c at screening (week ?3) ofor subjects currently treated with one antidiabetic medication: HbA1c > o = 7.2% and
•For subjects not currently treated with antidiabetic medications: HbA1c >o= 7.2% and
•HbA1c at baseline (Day 1)oHbA1c ? 9.0 %
•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

•Subjects requiring insulin therapy
•Subjects currently receiving 2 or more oral antidiabetic medications
•Subjects requiring systemic corticosteroids, unless treatment was discontinued at least 4 weeks before the screening visit
•Subjects receiving warfarin
•Subjects currently receiving thiazolidinediones, unless treatment was discontinued 8 weeks before the screening visit
•Significant diabetic complications (retinopathy, nephropathy, symptomatic neuropathy)
•Aspartate transaminase (AST), alanine transaminase (ALT) or alkaline phosphatase >o= 3.0 times ULN
•Total bilirubin >o= 1.5 mg/dL (>o= 26 μmol/L)
•Estimated GFR <40 mL/min/1.73 m2 (estimated by MDRD equation)
•Total fasting triglycerides > 500 mg/dL [5.6 mmol/L]
•TSH ?0.2 μIU/mL or >o=9.0 μIU/mL
•Hemoglobin < 10.0 g/dL (100 g/L)
•History of heart failure: NYHA Class 3 and 4 are excluded
•Uncontrolled hypertension, i.e., systolic BP> 160 mmHg; diastolic BP>110 mmHg, treated or untreated

发起方

Wyeth Research Division of Wyeth Pharmaceutical Inc., Clinical Research and Development