EUCTR2015-005740-34-DE进行中（未招募）1 期
Effectiveness of Dapagliflozin + Saxagliptin to revert from a standard basalbolusinsulin treatment (BBIT) regimen to a basal supported oral therapy(BOT) in patients with Type 2 Diabetes – a randomised double-blindedstudy – a randomised double-blinded study - Dapa-Saxa-BBIT
niversitätsklinikum Tübingen0 个研究点目标入组 4 人开始时间: 2016年9月29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
- 4
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
- •Type 2 diabetes
- •Age 18 - 75 years
- •Anti-GAD antibodies negative
- •C-peptide levels = 1.5 ng/mL
- •Fasting blood glucose = 126 mg/dl
- •HbA1c 8.0 – 10.5 %
- •BMI 25.0 – 45.0 kg/m2
- •Previous therapy with standard BBIT (basal insulin and at least
- •once daily bolus insulin) when the bolus insulin dose is not adjusted
- •to exercise or nutrient intake.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Use of any oral antidiabetic treatment except for metformin (i.e.,
- •sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2
- •inhibitors) or GLP-1 analogues within the last three months prior to
- •Repeated episodes of severe hypoglycaemia within the last six
- •months prior to Screening
- •History of diabetic ketoacidosis, praecoma diabeticum, or diabetic
- •Treatment with any other investigational drug within the last three
- •months before Screening
- •Acute infections within the last four weeks prior to Screening
- •Recurrent urogenital infections
- •History of pancreatitis
- •Anamnestic history of hypersensitivity to the study drugs or to
- •drugs with similar chemical structures
- •History of severe or multiple allergies
- •Concomitant participation in other clinical trials
- •Type 1 diabetes
- •Cardiovascular disease
- •Clinically relevant ventricular tachycardia or ventricular
- •fibrillation, 3rd degree AV block or Torsades de Pointes or
- •treatment with antiarrhythmic drugs.
- •Percutaneous coronary intervention within the past 6 months.
- •Any of the following within the past 6 months: myocardial
- •infarction (MI), coronary artery bypass surgery; unstable angina;
- •Uncontrolled unstable angina pectoris or history of pericarditis,
- •myocarditis, endocarditis.
- •Congestive heart failure NYHA class III or IV.
- •Increased risk of thromboembolism, e.g. subjects with a history
- •of deep leg vein thrombosis or family history of deep leg vein
- •thrombosis, as judged by the Investigator.
- •Malignancy including leukemia and lymphoma within the last 5y.
- •Liver disease such as cirrhosis or chronic active hepatitis.
- •Moderate or severe impaired liver function (serum AST or serum
- •ALT > 2.5 x ULN, serum total bilirubin = 2.0 mg/dl or serum
- •albumin = 3.5 g/dl)
- •Significant renal dysfunction (see also exclusion criteria laboratory
- •abnormalities).
- •State after kidney transplantation
- •Endocrine disease:
- •Acromegaly or treatment with growth hormone or similar drugs.
- •Chronic oral or parenteral corticosteroid treatment (=7
- •consecutive days of treatment) within 8 weeks; thyroid hormone
- •replacement is allowed if the dosage has been stable for at least 3
- •months and the TSH is within normal limits
- •Any of the following significant laboratory abnormalities:
- •eGFR (as calculated by the MDRD equation) < 60 ml/min at
- •Fasting triglycerides =700 mg/dl (=7.9 mmol/l)
- •Systolic blood pressure outside the range of 100–160 mmHg or
- •diastolic blood pressure above 95 mmHg at Screening
- •History of active substance abuse (including alcohol > 12g/day for
- •women and >24g/day for men) within the past 2 years.
- 另有 17 项未显示
研究者
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