EUCTR2012-000140-97-BG进行中（未招募）不适用
The efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapy - DUAL™ IV - SU Add-On
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 429
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
- •- Subjects with Type 2 Diabetes Mellitus
- •- Male or female = 18 years of age
- •- HbA1c 7.0-9.0% (53-75 mmol/mol)(both inclusive)
- •- Subjects on stable daily dose of sulphonylurea (= half of the max approved dose according to local label) with or without metformin (= 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
- •- Body Mass Index (BMI) = 40 kg/m^2
- •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 321
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 108
排除标准
- •- Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combination with metformin) = 90 days prior to screening visit (Visit 1)
- •- Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- •- Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
- •- Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
- •- Screening calcitonin = 50 ng/l
- •- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- •- Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
- •- Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator’s opinion
- •- Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product
- •- History of chronic pancreatitis or idiopathic acute pancreatitis
研究者
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