EUCTR2010-021560-15-IT进行中（未招募）不适用
DUAL™ I DUal Action of Liraglutide and insulin degludec in type 2 diabetes A 26 week randomised, parallel three-arm, open-label, multi-centre, multinational treat-to-target trial comparing fixed ratio combination of insulin degludec and liraglutide versus insulin degludec or liraglutide alone, in subjects with type 2 diabetes treated with 1-2 oral anti-diabetic drugs (OADs) with a 26 week extension. - DUAL™ I
OVO NORDISK0 个研究点目标入组 1,660 人开始时间: 2011年2月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,660
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 • HbA1c 7.0-10.0 % (both inclusive) with the aim of a median HbA1c of 8.3%. Accordingly, when approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c of below or equal to 8.3%, or when approximately 50% of the randomised subjects have a HbA1c of below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3% • Male or female, age 18 years or above • Subjects on stable dose of 1-2 OADs (metformin [`?¥ 1500 mg or max tolerated dose] or metformin [`?¥ 1500 mg or max tolerated dose] + pioglitazone [`?¥ 30 mg]) for at least 90 days prior to screening • BMI `?¤ 40 kg/m^2
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) • Treatment with GLP-1 receptor agonists (eg exenatide, liraglutide), sulphonylurea or dipeptidyl peptidase 4 (DPP-4) inhibitors within 90 days prior to trial • Impaired liver function, defined as alanine aminotransferese (ALAT) `?¥ 2.5 times Upper Normal Range (UNR) (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) • Impaired renal function defined as serum-creatinine `?¥ 133 µmol/l (`?¥ 1.5 mg/dl) for males and `?¥ 125 µmol/l (`?¥ 1.4) for females, or as allowed according to local contraindications for metformin (one retest analysed at the central laboratory within a week from first sample taken is permitted with the result of the last sample being the conclusive) • Screening calcitonin `?¥ 50 ng/L • Subjects with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) • Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months and planned coronary, carotid or peripheral artery revascularisation procedures • Severe uncontrolled treated or untreated hypertension (systolic blood pressure `?¥ 180 mm Hg or diastolic blood pressure `?¥ 100 mm Hg) • Acute treatment required proliferative retinopathy or maculopathy (macular oedema) • History of chronic pancreatitis or idiopathic acute pancreatitis
研究者
相似试验
已完成
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终止
4 期
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