Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine

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 Situation

Primary objective:

To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are switched to insulin glargine.

Secondary objective:

To determine:

change in HbA1c, comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine, change in weight, change in insulin dose.

lists of inclusion and exclusion criteria:

Inclusion Criteria:

• Patients with type 2diabetes inadequately controlled on a combination of OAD + NPH insulin for more than three months
• Stable OAD therapy for at least three months, according to the following specified daily dose: glibenclamide> 3, 5 mg, glipizid >5 mg, glimeperid >2mg, metformin>1000 mg, acarbose >150 mg
• HbA1c > 7,0%
• Ability to perform QoL assessment
• Body Mass Indes: women <30 and men <32

Exlusion criteria:

• Autoimmune diabetes, as defined by WHO
• Ongoing treatment with tiasolidindion drug
• Retinopathy with surgical treatment during preceding three months of study entry or requiring treatment within three months after study entry
• Drug abuse
• Hypersensitivity to insulin glagine excipients

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.