A randomised, double blind, cross-over trial comparing the safety and efficacy of insulin degludec and insulin glargine, both with insulin aspart as mealtime insulin in subjects with type 1 diabetes - SWITCH 1

ovo Nordisk A/S0 个研究点目标入组 446 人开始时间: 2014年7月4日最近更新: 2016年4月25日

适应症

试验速览

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•1. Male or female, age = 18 years at the time of signing informed consent
•2. Subjects fulfilling at least one of the below criteria:
•a) Experienced at least one severe hypo episode within the last year (according to the ADA definition, April 2013)
•b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi
•c) Hypoglycaemic symptom unawareness
•d) Diabetes mellitus duration for more than 15 years
•e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (= 70 mg/dL [= 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening)
•3. Type 1 diabetes mellitus (diagnosed clinically) = 52 weeks prior to Visit 1
•4. Current treatment with a basal-bolus regimen (consisting of neutral protamine Hagedorn (NPH) insulin OD / BID or insulin detemir (IDet) OD / BID plus 2-4 daily injections of any rapid acting or fast acting meal time insulin) or CSII (with rapid acting insulin) for = 26 weeks prior to Visit 1
•5. HbA1c = 10% by central laboratory analysis
•6. BMI = 45 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 424
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 22

•1. Treatment with IGlar or IDeg within the last 26 weeks prior to Visit 1 (short term use [= 2 weeks] is allowed, but not within 4 weeks prior to screening)
•2. Use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1

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