Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine (QoL)
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About
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.
Enrollment
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Inclusion and exclusion criteria
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.
Trial design
Primary purpose
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Interventional model
Masking
26 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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