EUCTR2016-002183-13-SE进行中（未招募）1 期
Effect on fasting plasma glucose (FPG) of once daily oral administration during 28 days of O304 suspension in subjects with Type 2 Diabetes (T2D). A single-centre, randomised, parallel-group, double-blinded, placebo controlled Phase IIa study (TELLUS).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Betagenon AB
- 入组人数
- 66
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
- •For inclusion in the study, subjects must fulfil the following criteria:
- •1.Willing and able to give written informed consent for participation in the study.
- •2.Male and females aged 18-80 years inclusive.
- •3.Female subjects must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone 25-140 IE/L and estradiaol <200 pmol/L is confirmatory]).
- •4.Male subjects must be willing to use condom and contraceptive methods with a failure rate of < 1% to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until three months after dosing of the IMP.
- •5.Diagnosed with uncomplicated T2D defined as HbA1c of =6.5% and =9.0% at the Screening Visit.
- •6.On stable T2D treatment with Metformin monotherapy for = three months prior to Screening.
- •7.BMI, measured as body weight (kg) /height (m)2, = 40 kg/m2.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •Subjects must not enter the study if any of the following exclusion criteria are fulfilled:
- •1.History of or presence of (as found at Visit 1) any clinically significant disease, disorder or condition which, in the opinion of the Investigator, may either put the subject at risk due to participation in the study, or influence the results or the subject’s ability to participate in the study.
- •2.History of Myocardial Infarction (MI), unstable angina, stroke or Transient Ischemic Attack (TIA).
- •3.Congestive heart failure defined as New York Heart Association (NYHA) class III-IV.
- •4.Any clinically significant illness, medical or surgical procedure or trauma within four weeks of the first administration of study medication, as judged by the Investigator.
- •5.Any clinically significant abnormalities in physical examination, ECG or clinical chemistry results at as judged by the Investigator. The following specific exclusion criteria apply to the selected clinical chemistry results:
- •-Creatinine clearance <60mL/min (estimated with Cockroft-Gault formula).
- •-Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
- •-Total bilirubin >2.0 mg/dL (34.2 µmol/L).
- •6.Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
- •7.After 10 minutes of supine rest abnormal vital signs defined as any of the following at the Screening Visit (Visit 1):
- •-Systolic blood pressure > 165 mm Hg
- •-Diastolic blood pressure > 100 mm Hg
- •-Heart rate < 40 or > 85 beats per minute
- •8.Any condition that is contraindicated with MRI such as, but not limited to, claustrophobia, have a history of brain or heart surgery, any metallic implant (e.g. pacemaker, cochlear implant, hip joint replacement), permanent make-up, work as metalworker or welder or have other MRI contraindications or inability to stay in the supine position for 45 minutes.
- •9.Any clinically significant incidental finding at the MRI scan performed before randomisation.
- •10.Known or suspected history of significant drug abuse.
- •11.History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.
- •12.History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to O304.
- •13.Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening.
- •14.Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study including drug treatment within three months of the first administration of the IMP in this study. Subjects consented and screened but not dosed in previous phase I studies will not be excluded.
- •15.Unwilling or unable to adhere to all study visits according to the Clinical Study Protocol (e.g no longer trip than seven days is allowed).
- •16.Investigator considered subject unlikely to comply with study procedures, restrictions and requirements.
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