The Impact of Initiating/Switching to Insulin Detemir on Emotional Well-being and Treatment Satisfaction
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01542476
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. The aim of this study is to assess the well-being of patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type 2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting basal insulin analogue is needed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 299
Inclusion Criteria
- Any subject with type 1 or type 2 diabetes not optimally controlled (HbA1c above 7.5%) in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue
- Subjects with type 1 diabetes should have been treated with insulin for at least 12 months
- Potential pre-study treatment with insulin detemir (Levemir®) should have started no more than two months before baseline
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IDet users insulin detemir -
- Primary Outcome Measures
Name Time Method Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS) Baseline, month 6
- Secondary Outcome Measures
Name Time Method Change in Fasting blood glucose (FBG) Baseline, month 6 Change in body weight Baseline, month 6 Hypoglycaemic episodes Month 6 Adverse events Month 6 Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ) Baseline, month 6 Change in HbA1c (glycosylated haemoglobin) Baseline, month 6