Effect of different insulin therapy regimens on arterial compliance, endothelial function, and cardiac autonomic function in poorly controlled type 2 diabetic patients on oral antidiabetic therapy: a pilot study. - INSUVASC

INTERVENTION: Product Name: Novorapid Pharmaceutical Form: Solution for injection INN or Proposed INN: Insuline asparte Concentration type: equal Concentration number: 1000 U‐ Product Name: Levemir Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin detemir Concentration type: equal Concentration number: 300 U- CONDITION: Poorly controlled type 2 diabetes; MedDRA version: 8.1 Level: PT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent PRIMARY OUTCOME: Main Objective: To compare the effects of improved glycemic control in the medium term (4-5 weeks) of fasting and/or postprandial blood glucose levels achieved with different insulin regimens on arterial stiffness, endothelial function, autonomic nervous system, and body composition in patients with type 2 diabetes who are poorly controlled despite maximum tolerated oral dual antidiabetic therapy combining at least metformin and an insulin secretagogue. Primary endpoint(s): All quantitative parameters will be summarized descriptively within each treatment modality group and for each time point at which they are collected. The descriptive statistical analysis will include for each quantitative parameter at each time: mean, standard deviation, minimum, maximum, median and quartiles, number of missing values. Secondary Objective: INCLUSION CRITERIA: - Subject covered by the social security system, - Subject giving informed and free consent, - Patient able to monitor their capillary blood glucose levels, - Patient able to understand the recommended insulin dose changes, - Can be easily contacted by telephone, - Subject aged 30 to 72 years, - Type 2 diabetes diagnosed for more than one year, - HbA1c measured by DCA between 7.1 and 12%, - On treatment for at least 2 months including metformin and an insulin secretagogue (sulfonylureas or glinides) at maximum tolerated doses, - Body mass index between 20 and 37 kg/m², - In case of treated hypertension, treatment unchanged for 3 months, - In case of dyslipidemia treated, treatment unchanged for 3 months, 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 ra