EUCTR2016-004878-17-GB进行中（未招募）1 期
The Effect of a SGLT2 inhibitor on Glucose flux, Lipolysis and Exercise in type 2 Diabetes - SINGLED
niversity of Leicester0 个研究点目标入组 18 人开始时间: 2017年3月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
入选标准
- •Able in the opinion of the investigator, and willing to give informed consent obtained before any study-related activities.
- •Diagnosis of type 2 diabetes greater than 12 months.
- •Single, dual or triple therapy glucose lowering agents comprising of sulphonylureas, biguanides and DDP-IV.
- •No previous exposure to SGLT2 inhibitors.
- •Aged 18 – 75 years.
- •BMI of less than 40.
- •HbA1c of greater or equal to 6.5% and less than 9% within 1 month of screening.
- •Able to comply with the study and the study procedures.
- •Patients who are or who have previously been involved in research are eligible provided they have not received an investigational drug within one month of entry into the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Participants over 75.
- •Participants under 18.
- •Participants who cannot adequately understand verbal and / or written explanations given in English.
- •Clinical suspicion of Hypoglycaemic unawareness.
- •LADA –latent autoimmune diabetes in adults due to differing nature of the illness/Type 1.
- •Confirmed excessive and compulsive drinking of alcohol i.e. alcohol abuse as determined from GP medical notes by the Fast Alcohol Screening Test (FAST) or history of previous alcohol abuse.
- •Has a history of chronic pancreatitis
- •Restricted food intake - Determined by history.
- •Diagnosis of osteoporosis confirmed by DEXA scan.
- •Participants on insulin, insulin analogs or GLP-1 in the preceding 6 months.
- •Proliferative retinopathy that has required acute treatment within last three months.
- •Moderate to severe renal impairment (creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2.
- •History of unstable or rapidly progressing renal disease.
- •Severe hepatic insufficiency / and or significant abnormal liver function defines as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and / or alanine aminotransferase (ALT) > 3ULN.
- •Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody.
- •Congestive heart failure defined as New York Heart Association (NYHA) class III and IV, unstable or acute congestive heart failure.
- •Uncontrolled cardiac arrhythmias.
- •Uncontrolled hypertension. (BP greater than 160/90).
- •Mental incapacity.
- •Pregnancy or breast feeding women.
- •Those of child-bearing potential not taking adequate contraception precautions. ?Adequate protection is defined as barrier protection, oral contraceptive pill or intrauterine device.
- •Volume depleted patients, patients at risk of volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
- •History of unstable angina.
- •Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
- •Hospitalisation for unstable angina or acute myocardial infarction within 2 months prior to enrolment.
- •Acute Stroke or TIA within two months prior to enrolment.
- •Less than two months post coronary artery revascularisation.
- •History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalisation) within 1 month prior to the screening visit.
- •Known or suspected allergy to study products.
- •Known Lactose-intolerant.
- •Have severe and enduring mental health problems
- •Are not primarily responsible for their own care
研究者
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