Efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult Subjects with type 2 diabetes - onset® 3

ovo Nordisk A/S0 个研究点目标入组 218 人开始时间: 2013年4月16日最近更新: 2015年8月24日

适应症

试验速览

暂无简介。

•Age =18 years at time the informed consent is signed by the Subject (Visit 1)
•Type 2 diabetes (diagnosed clinically) = 6 months prior to the screening visit (Visit 1)
•Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH 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 Dipeptidyl peptidase-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) 7.5-9.5% (58 – 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1)
•b) 7.5-9.0% (58 – 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 118
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Any use of bolus insulin, except short-term use due to intermittent illness (no longer than14 days of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
•Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1)
•Recurrent severe hypoglycaemia (more than one 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)

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