Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination with Insulin Glargine and Metformin in Adults with Type 2 Diabetes - onset® 2

ovo Nordisk A/S0 个研究点目标入组 676 人开始时间: 2013年5月17日最近更新: 2015年7月10日

适应症

试验速览

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•Female or male, age = 18 years at the time of signing inform consent
•Type 2 diabetes (diagnosed clinically) = 6 months at time of screening (visit 1)
•Treated with basal insulin for at least 6 months prior to screening (visit 1)
•Current once daily treatment with insulin NPH, insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1)
•Current treatment with:
•a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
•b. metformin in combination with sulfonylurea (SU) or glinide or DPP-IV inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg
•HbA1c by central laboratory:
•a. 7.0 - 9.5% (53 – 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1)
•b. 7.0 - 9.0% (53 – 75 mmol/mol) (both inclusive) in the metformin + other OAD (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1)
•Body mass index (BMI) = 40.0 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 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 276

•Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1)
•Use of GLP-1 agonists and/or TZDs within the last 3 months prior to screening (visit 1)
•Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1)
•Cardiovascular disease, within the last 6 months prior to screening (visit 1), defined as: stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris or coronary arterial bypass graft or angioplasty

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