Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine (QoL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00518427|
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : December 7, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Type 2||Drug: Insulin Glargine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
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.
- The fear of hypoglycaemia scale (HFS) [ Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up. ]
- 12 - Item Well-Being Questionnaaire (WBQ12) [ Time Frame: before the switch to insulin glargine and at 3 and 9 months of follow up. ]
- Glycaemic controll will be asessed by HbA1c values [ Time Frame: week 12 and week 40 ]
- Incidence of symptomatic hypoglycemia and severe hypoglycemia [ Time Frame: sreening to follow-up phases ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518427
|Sanofi-Aventis Administrative Office|
|Study Director:||Margareta Olsson-Birgersson||sanofi-aventis, Sweden|