EUCTR2015-002790-38-GB进行中（未招募）1 期
TriMaster: Randomised Double-Blind Crossover study of a DPP4 inhibitor, SGLT2 inhibitor and thiazolidinedione as third line therapy in patients with type 2 diabetes who have suboptimal glycaemic control on dual therapy with metformin and a sulphonylurea - TriMaster v1
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 520
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
- •Clinical diagnosis of Type 2 diabetes
- •Age =30 and =80
- •Currently treated with either metformin alone, or two classes of oral glucose-lowering therapy (given either as separate or combined medications), that do not include a DPP4-inhibitor, a SGLT2-inhibitor or a thiazolidinedione.
- •Diabetes duration =12months
- •No change in diabetes treatment (new treatments or dose change) within previous 3 months
- •HbA1c >58mmol/mol (7.5%) & = 110mmol/mol (12.2%) – confirmed at screening visit
- •eGFR = 60mls/min/1.73m² - confirmed at screening visit
- •Able and willing to give informed consent
- •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 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 260
排除标准
- •Changes in glucose-lowering therapy or dose within last 3 months
- •HbA1c = 58mmol/mol (7.5%) & >110mmol/mol (12.2%)
- •eGFR <60mls/min/1.73m².
- •Diabetes duration <12 months
- •ALT >2.5 x upper limit of the assay normal range or known liver disease, specifically >30 µmol/L that is associated with other evidence of liver failure.
- •Insulin treated within the last 12 months
- •Treatment with study dugs within the last 3 months
- •Limb ischaemia shown by absence of both pulses in one or both feet
- •Currently treated with corticosteroids
- •Active infection (any infection requiring antibiotics at present)
- •Active foot ulcer
- •Recent (within 3 months) significant surgery or planned surgery (excluding minor procedures)
- •Acute cardiovascular episode (angina, myocardial infarction, stroke, transient ischemic episode) occurring within the previous 3 months
- •History of heart failure or current use of loop diuretic therapy (Furosemide or Bumetanide)
- •History of bladder carcinoma or current/ongoing investigation for macroscopic haematuria
- •History of Diabetic Ketoacidosis or pancreatitis
- •Pregnant, breastfeeding or planning a pregnancy over the study period
- •Concurrent Participation on another Clinical Trial of an Investigational Medicinal Product
- •Unable or unwilling to give informed consent
研究者
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