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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>insulin glargine | Drug: Insulin Glargine<br>* Lantus (insulin glargine [rDNA origin] injection), individual dosing , subcutaneous injection, 100 IU/ml. Duration of treatment will be judge by the investigator. Last QoL assessed in the study will be 9 months after start of glargine treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fear of hypoglycaemia scale (HFS) |  | before the switch to insulin glargine and at 3 and 9 months of follow up. | 
| 12 - Item Well-Being Questionnaaire (WBQ12) |  | before the switch to insulin glargine and at 3 and 9 months of follow up. | 
| Glycaemic controll will be asessed by HbA1c values |  | week 12 and week 40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic hypoglycemia and severe hypoglycemia |  | sreening to follow-up phases |