PER-132-08已完成未知
A Phase II, Randomized, Double-Blind, Placebo-and Active-Controlled, Multi-center Study to Determine the Efficacy and Safety of TAK-379 in Subjects With Type 2 Diabetes
试验速览
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
- 18 至 80（—）
- 性别
- All
入选标准
- •The subject is a man or woman 18 to 80 years of age, inclusive, and meets one of the following criteria: A historical diagnosis of type 2 diabetes mellitus without chronic use (defined as> 7 days) of antidiabetic treatment and history of 8 weeks of diet and exercise at the time of selection o A historical diagnosis of type 2 diabetes mellitus with a stable dose of metformin as monotherapy for at least 3 months before selection.
- •The subject has an HbA1c between 7.5% and 10.0%, inclusive
- •The subject has a fasting C-peptide concentration> 0.8 ng / mL (0.26 nmol / L).
- •The subject has other chronic medications that have been stable (no dose or medication changes) for at least 4 weeks before Selection,
- •The body mass index (BMI) of the subject at the time of Selection is> 23 kg / m2 and <45 kg / m2.
- •The subject is able to understand and comply with the requirements of the protocol.
- •The subject or his legally authorized representative signs a written informed consent form before the start of any study procedure.
- •The subject is able and willing to monitor their own blood glucose concentrations with a homemade glucose monitor.
- •A female subject who is not pregnant or nursing. A female subject of childbearing age must have a pregnancy test using negative human chorionic gonadotropin (HCG) in the Selection and in Week -1 before the administration of the first dose of the double-blind study medication.
- •Women of childbearing age who are sexually active agree to use an appropriate contraceptive method from the selection and for the entire duration of the study and up to 1 month after the last dose of the study medication. Women who are NOT of childbearing age are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation) or who are postmenopausal (defined as at least 2 years since the last regular menstruation). Acceptable contraceptive methods are defined in Section 9.1.11 Procedure for Contraceptives and Pregnancy Prevention.
- •The subject´s compliance with the study´s blind medication during the induction phase is at least 75% and does not exceed 125% based on the tablet counts made by the study staff.
排除标准
- •The subject´s systolic blood pressure is> 160 mmHg or the diastolic blood pressure is> 100 mmHg in repeated measurements.
- •The subject has a history of bladder cancer or a history of a cancer that has been in remission for <5 years prior to Selection (the history of basal cell carcinoma or squamous cell carcinoma is allowed in Stage 1).
- •The subject has an HbAlc <7.5% and> 10.0%.
- •Creatine phosphokinase (CPK)> 5 x LNS in the selection.
- •The subject has a hemoglobin <12 g / dL (120 gm / L) for men and <10 g / dL (100 gm / L) for women.
- •The subject has a alanine aminotransferase (ALT) and aspartate aminotransferase (AST)> 2.5 the upper normal limit (LNS).
- •The subject has a total bilirubin> 1.5 x LNS in the selection.
- •The subject has a serum triglyceride concentration> 400 mg / dL (4.5 mmoI / L),
- •The subject has an estimated glomerular filtration rate (VFG) <60 mL / min using the Diet Modification equation in Kidney Disease (MDER) or the Cockroft-Gauli equation.
- •The subject has an abnormal level of thyroid stimulating hormone (TSH) defined according to the normal values of the central laboratory.
- •The subject has a positive result for hepatitis B surface antigen (HBsAG) or hepatitis C antibody (anti-HCV).
- •The subject has a urinary creatine / albumin ratio> 1000 pg / mg (113 mg / mol) in the selection.
- •The subject has a history of microscopic or macroscopic hematuna
- •The subject has two consecutive positive urine tests using an unexplained test strip and> 3 CKD per high resolution field.
- •The subject has a history of laser treatment for proliferative diabetic retinopathy in the 6 months prior to selection.
- •The subject has diabetic gastroparesis which, in the opinion of the researcher, is moderate or severe and could alter the absorption of the study medication.
- •The subject has Class III or IV heart failure from the New York Cardiology Association (NYHA).
- •The subject has had coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, unstable angina pectoris, clinically significant abnormal ECG, stroke or transient ischemic attack in the 6 months prior to selection.
- •The subject has a history of any hemoglobinopathy that could affect the determination of HbA1c.
- •The subject has received probucol treatment for 1 year before randomization.
- •The subject has donated or received any blood product in the 12 weeks prior to the Selection.
- •The subject has received treatment for> 7 days in the 8 weeks prior to randomization with any of the following: oral or systemically injected glucocorticoids (topical or inhaled glucocorticoids are allowed), over-the-counter or weight-loss medications required Prescription 9 PPAR agonists, including derivatives of fibric acid (e.g., fenofibrate, gemfibrozil, Pioglitazone, Rosiglitazone), Niacin, Ezetemibe, Bile acid fixing agents
- •The subject is treated with insulin chronically.
- •The subject has received any investigational medication in the 4 weeks prior to the Selection.
- •The subject is currently taking warfarin or phenytoin at the time of Selection.
- •The subject has a history of hepatitis B infection, hepatitis C or human immunodeficiency virus.
- •The subject is hypersensitive to TAK-379 or its excipients.
- •The subject has a history of substance abuse (defined as illicit drug use) or a history of alcohol abuse (de
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