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

ovo Nordisk AS0 个研究点目标入组 95 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1)
•Body mass index (BMI) equal to or below 40.0 kg/m2
•HbA1c by central laboratory: a. 7.0 - 9.5% (53 â?? 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 â?? 75 mmol/mol) (both inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1)
•Treated with basal insulin for at least 6 months prior to screening (visit 1)
•Type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1)

•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)
•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
•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)
•Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1)

发起方

ovo Nordisk AS