NCT02965443终止4 期
Effectiveness of Dapagliflozin + Saxagliptin to Revert From a Basal-bolus Insulin Treatment (BBIT) Regimen to a Basal Supported Oral Therapy (BOT) in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen
研究概览
简要总结
To perform a study that investigates the effectiveness of adding the SGLT2 inhibitor dapagliflozin + the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin vs placebo to revert from a BBIT regimen to a BOT regimen in patients with type 2 diabetes.
详细描述
This will be a phase IV study investigating the efficacy and safety of adding the SGLT2 inhibitor dapagliflozin together wih the DPP-4 inhibitor saxagliptin to an intensified insulin treatment regimen. Because BOT is superior to BBIT in respect to the development of bodyweight, hypoglycaemia and patient satisfaction in type 2 diabetes, we hypothesize that the combined addition of the SGLT2 inhibitor dapagliflozin with the DPP-4 inhibitor saxagliptin is effective and safe to revert from a BBIT to a BOT treatment regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Age 18 - 75 years
- •Anti-GAD antibodies negative (Glutamic Acid Decarboxylase)
- •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 BBIT (basal insulin and at least once daily bolus insulin)
排除标准
- •Use of any oral antidiabetic treatment except for metformin (i.e., sulphonylureas, DPP-IV inhibitors, thiazolidinediones, SGLT-2 inhibitors (Sodium dependent glucose transporter) or GLP-1 analogues (glucagone like peptide) within the last three months prior to Screening
- •Repeated episodes of severe hypoglycaemia within the last six months prior to Screening
- •History of diabetic ketoacidosis, precoma diabetica, or diabetic coma
- •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; or stroke.
- •Uncontrolled unstable angina pectoris or history of pericarditis, myocarditis, endocarditis. Congestive heart failure NYHA (New York Heart Association) 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.
- •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 Screening 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 > 40g/day) within the past 2 years.
- •Pregnancy or childbearing potential without adequate contraception
- •Present therapy with systemic steroids
- •Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s (selective serotonin reuptake inhibitor)
- •Potentially unreliable subjects, and those judged by the investigator to be unsuitable for the study.
- •Contraindications for Magnetic resonance (MR) scanning such as persons with cardiac pacemaker and implants out of metal or claustrophobia
研究组 & 干预措施
Verum
Active Comparator
Dapagliflozin 10 mg + Saxagliptin 5 mg, each once daily, for 24 weeks
干预措施: Dapagliflozin 10 mg + Saxagliptin 5 mg (Drug)
Placebo
Placebo Comparator
Placebo 1 10 mg + Placebo 2 5 mg, each once daily, for 24 weeks
干预措施: Placebo 1 10 mg + Placebo 2 5 mg (Drug)
结局指标
主要结局
Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen
时间窗: 24 weeks
Percentage of subjects achieving a HbA1c ≤ 7.5% and having a reversal from a BBIT to a BOT regimen with treatment of dapagliflozin/saxagliptin or placebo
次要结局
- changes in daily insulin dose between groups(24 weeks)
- changes in microalbuminuria between groups(24 weeks)
- changes in well being and disease perception between groups(24 weeks)
- changes in fear of hypoglycemia between groups(24 weeks)
- changes in fasting blood glucose between groups(24 weeks)
- changes in body fat content between groups(24 weeks)
- changes in HbA1c between groups(24 weeks)
- changes in hypoglycaemic events between groups(24 weeks)
- changes in bodyweight between groups(24 weeks)
- changes in liver fat content between groups(24 weeks)
- changes in intra-nasal insulin-induced brain fMR (functional magnetic resonance) imaging results between groups(24 weeks)
- changes in the blood lipid profile between groups(24 weeks)
- changes in body fat distribution between groups(24 weeks)
- changes in blood pressure between groups(24 weeks)
研究者
研究点 (1)
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