EUCTR2018-004120-11-GB进行中（未招募）1 期
Triple Therapy for Type 1 Diabetes with Insulin, Semaglutide and Dapagliflozin - TTT1 study
HS Greater Glasgow and Clyde0 个研究点目标入组 114 人开始时间: 2020年3月16日最近更新:
适应症
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
- 114
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
- •1) Type 1 Diabetes for at least 1 year on stable multiple daily (four or more) injections (MDI) of insulin or continuous subcutaneous insulin infusion (CSII) for the previous three months.
- •2) C-peptide < 0.23 nM
- •3) Minimum dose of insulin: 0.5 U/kg for MDI and 0.4 U/kg for CSII
- •4) Regularly measuring blood glucose four or more times daily by fingerprick, (or by flash or continuous glucose monitoring).
- •5) HbA1c >7.5%
- •6) Well versed in Carbohydrate (CHO) counting*
- •7) Age 18-70 years.
- •8) BMI =25 kg/m2.
- •*In the opinion of the site Principal Investigator
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1) Type 1 diabetes for < 12 months, type 2 diabetes, chronic pancreatitis, MODY
- •2) Previous use of any agent other than insulin for glycaemic control in the last three months.
- •3) History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalisation) within three months prior to the screening visit.
- •4) Following ketogenic diet, low (<50g/day) carbohydrate diet or intermittent fasting.
- •5) Hypoglycaemia unawareness* or frequent episodes of severe hypoglycaemia as defined by more than one episode requiring medical assistance, emergency care (paramedics or emergency room care), or glucagon therapy administered by a third-party individual within three months prior to the screening visit
- •6) Symptoms of poorly controlled diabetes
- •7) Participation in a weight loss program with ongoing weight loss, or in an intensive exercise program
- •8) History of bariatric or other weight-loss surgery within 12 months prior to the screening visit
- •9) History of Addison’s disease or chronic adrenal insufficiency
- •10) History of diabetes insipidus
- •11) Hepatic disease or cirrhosis
- •12) Aspartate Aminotransferase (AST) > 3 X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) > 3 X ULN
- •13) Serum Total Bilirubin > 2 X ULN unless exclusively caused by Gilbert’s Syndrome
- •14) Haemoglobin < 110 g/L (11.0 g/dL) for men; haemoglobin < 100 g/L (10.0 g/dL) for women
- •15) Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous three months or history of congestive heart failure
- •16) End stage renal disease on haemodialysis and/or eGFR < 60 ml/min/1.73m2
- •17) HIV or Hepatitis B/C positive status
- •18) Any other life-threatening, non-cardiac disease
- •19) History of pancreatitis or cystic fibrosis
- •20) Women who are pregnant, planning pregnancy or breast-feeding and women of childbearing potential (WOCBP) who are not established on a method of adequate contraception considered highly effective (see Appendix 2) and willing to continue it for the duration of the study and for at least two months after last dose of IMP.
- •21) Inability to give informed consent
- •22) History of gastroparesis
- •23) History of medullary thyroid carcinoma or MEN 2 syndrome
- •24) History of hypersensitivity reaction to GLP-1 agonists or SGLT2 inhibitors or known hypersensitivity to any of the excipients
- •25) Known gallstones (history of cholecystectomy is not an exclusion criterion)
- •26) History of alcohol problem or drug abuse
- •27) Hypertriglyceridemia (>500 mg/dl)
- •28) Recurrent genital mycotic infection (more than one episode in last six months)
- •29) Hypovolaemia
- •30) Any malignancy except treated in situ malignancy and basal cell carcinoma of the ski
- •31) Unexplained haematuria (dipstick positive on two occasions one week apart) and/or active bladder cancer
- •32) Proliferative retinopathy (on basis of photographic retinal screening which must have been performed within the last 12 months
- •33) Use of an investigational agent or therapeutic regimen within 90 days of study
- •34) Participation in any other concurrent interventional clinical trial
- •35) Unlikely to be able to comply with study requirements*
- •* In the opinion of the site Principal Investigator
研究者
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