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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

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.