The Impact of Initiating/Switching to Insulin Detemir on Emotional Well-being and Treatment Satisfaction

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir

• 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

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-03-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

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