Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine (QoL)
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.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- The fear of hypoglycaemia scale (HFS) [ Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up. ] [ Designated as safety issue: No ]
- 12 - Item Well-Being Questionnaaire (WBQ12) [ Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up. ] [ Designated as safety issue: No ]
- Glycaemic controll will be asessed by HbA1c values [ Time Frame: week 12 and week 40 ] [ Designated as safety issue: No ]
- Incidence of symptomatic hypoglycemia and severe hypoglycemia [ Time Frame: sreening to follow-up phases ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Drug: Insulin Glargine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518427
|Sanofi-Aventis Administrative Office|
|Study Director:||Margareta Olsson-Birgersson||sanofi-aventis, Sweden|