DUAL™VII - Insulin degludec/liraglutide (IDegLira) vs. basal-bolus therapy: A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in subjects with type 2 diabetes mellitus - DUAL™VII

ovo Nordisk A/S0 个研究点目标入组 500 人开始时间: 2015年5月5日最近更新: 2016年12月12日

适应症

试验速览

暂无简介。

•- Male or female, age =18 years at the time of signing informed consent
•- Type 2 diabetes subjects (diagnosed clinically) = 6 months prior to screening
•- HbA1c 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
•- Current treatment with IGlar for at least 90 calendar days prior to screening
•- Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of ± 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
•- Stable daily dose of metformin (=1500 mg or max. tolerated dose) for at least 90 calendar days prior to screening
•- 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 375
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 125

•- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
•- Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
•- Impaired liver function, defined as alanine aminotransferase (ALT) =2.5 times upper limit of normal
•- Renal impairment eGFR <60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
•- Screening calcitonin =50 ng/L
•- History of pancreatitis (acute or chronic)
•- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

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