EUCTR2009-013881-25-PL进行中（未招募）不适用
Phase IIb, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12-Week Treatment with ASP1941 in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone - The BALANCE Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 630
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
- •· Subject is male or female of ³ 18 years of age at Visit 1.
- •· Subject has been diagnosed with T2DM for at least 6 months.
- •· Subject has inadequate glycemic control indicated by an HbA1c level
- •between 7.0% and 9.5% at start of the placebo run-in period at
- •Visit 1 AND does not meet any of the FPG discontinuation criteria.
- •· Subject has been on a stable dose of at least 1500 mg/day metformin
- •monotherapy for at least 6 weeks prior to Visit 1.
- •· Subject is on a stable diet and exercise program (for at least 6 weeks
- •prior to Visit 1) and is willing to remain on this program for the
- •duration of the study.
- •· Subject has a body mass index (BMI) 20 – 45 kg/m2 at Visit 1.
- •· Female subject of childbearing potential has a negative serum
- •pregnancy test (human chorionic gonadotropin [hCG]) at Visit 1 and
- •agrees to use an acceptable form of contraception throughout the
- •duration of the study OR is at least 1 year post-menopausal (defined
- •as amenorrhea for at least 1 year) or surgically sterile. Acceptable
- •methods of contraception are: oral or injectable hormonal
- •contraceptives, contraceptive patch, intra-uterine devices, vaginal
- •hormonal rings, or sterilization by surgery and only in combination
- •with a male condom, a vaginal diaphragm or cervical caps. Male
- •study subjects should be advised to use a male condom in addition to
- •having their partner use another acceptable method during the study
- •and for 3 months after the last dose.
- •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
- •· Subject has any known complication of T2DM indicating a late
- •disease state that in the investigator’s opinion should preclude the
- •subject from participation.
- •· Subject has type 1 diabetes mellitus.
- •· Subject is in need of insulin therapy or has received insulin within
- •3 months prior to Visit 1, with the exception of acute use of <7 days.
- •· Subject has a serum creatinine higher than upper limit of normal
- •range at Visit 1.
- •· Subject has an alanine aminotransferase (ALT) and/or aspartate
- •aminotransferase (AST) higher than 3 times upper limit of normal
- •range or has a total bilirubin more than 2 times upper limit of normal
- •at Visit 1.
- •· Subject has a urinary microalbumin/creatinine ratio above or equal to
- •300 mg/g at Visit 1.
- •· Subject has a symptomatic urinary tract infection (UTI) or
- •symptomatic genital infection at Visit 1 or during the placebo run-in
- •period, including just prior to randomization at Visit 2.
- •· Subject has persistent, uncontrolled severe hypertension as indicated
- •by a systolic blood pressure >180 mmHg or a diastolic blood
- •pressure of >110 mmHg taken in a sitting position after 5 minutes of
- •rest on at least 2 measurements (within 30 minutes of each other) at
- •· Subject has a significant cardiovascular disease, such as myocardial
- •infarction or a vascular intervention (e.g. angioplasty or stent) within
- •3 months prior to Visit 1, or history of heart failure (New York Heart
- •Association [NYHA] Class III-IV).
- •· Subject is known to have hepatitis or be a carrier of hepatitis B
- •surface antigen (HBsAg), hepatitis C virus (HCV) antibody (enzyme
- •linked immunosorbent assay [ELISA] plus confirmatory test), or is
- •known positive for human immunodeficiency virus (HIV) HIV-1 and/or HIV-2.
- •· Subject is currently receiving an excluded medication (loop-diuretics
- •or systemic corticosteroids) or has received any other oral antidiabetic
- •drug except for metformin within 3 months prior to Visit 1.
- •· Subject has history of lactic acidosis.
- •· Subject has a history of drug or alcohol abuse/dependency within
- •12 months prior to Visit 1 as defined in the Diagnostic and Statistical
- •Manual-IV (DSM-IV).
- •· Subject has had a malignancy in the last 5 years, except for
- •adequately treated basal or squamous cell carcinoma of the skin or
- •carcinoma in situ of the cervix.
- •· Female subject who is pregnant, lactating or pre-menopausal with
- •positive serum pregnancy test (hCG) at Visit 1 or has an intention of
- •becoming pregnant.
- •· Subject has an unstable medical or psychiatric illness.
- •· Subject has known or suspected hypersensitivity to ASP1941 or any
- •components of the formulations used.
- •· Subject has previously received ASP1941.
- •· Subject is concurrently participating in another drug study or has
- •received an investigational drug within 30 days (or the limit set by
- •national law, whichever is longer) prior to Visit 1.
- •· Subject has any concurrent illness which, in the opinion of the
- 另有 4 项未显示
研究者
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