A multicenter clinical trial to evaluate quality of life in patients with Type 2 diabetes before and after changing therapy to a combination of insulin glargine and oral antidiabetic drugs in a real life situatio

Conditions: Patients with Type 2 diabetes inadequately controlled on a combination of highest tolerable dose of oral antidiabetic drugs (OAD) + neutral protamine hagedorn (NPH) insulin for more than 3 months

Registration Number: EUCTR2005-000959-15-SE

Lead Sponsor: sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Patients with Type 2 diabetes inadequately controlled on a combination of highest tolerable dose of OAD + NPH insulin for more than 3 months
•HbA1c >7.0 %
•Age >18 years
•Willingness to participate
•Ability to perform QoL assessment
•Body Mass Index (BMI = weight [kg] / height [m] x height [m]): < or equal to 35 kg/m2
•Has been given written and verbal information and has had opportunity to ask questions about the study
•Signed consent (written) to participate in the study

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Autoimmune diabetes, as defined by the World Health Organization (WHO)
•Ongoing treatment with tiazolidindion (TZD) drug
•Inability to comply with study procedures
•Retinopathy with surgical treatment (laser photocoagulation or vitrectomy) during the preceding 3 months of study entry or requiring treatment within 3 months after the study entry
•Drug abuse
•Hypersensitivity to insulin glargine or any excipients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess QoL changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of OAD + NPH insulin treatment that are switched to insulin glargine. ;Secondary Objective: To determine:<br>•change in HbA1c<br>•comparison of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine <br>•change in weight <br>•change in insulin dose<br>;Primary end point(s): •Diabetes Treatment Satisfaction Questionnaire (DTSQ) <br>•The fear of hypoglycaemia scale (HFS)<br>•12-Item Well-Being Questionnaire (WBQ12)<br>Glycaemic control will be assessed by HbA1c values<br><br>Incidence of symptomatic hypoglycemia and severe hypoglycemia

Secondary Outcome Measures