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

Novo Nordisk A/S299 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

299

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Alphen aan den Rijn, Netherlands

Outcomes

Primary Outcomes

Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS)

Time frame: Baseline, month 6

Secondary Outcomes

Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ)

Time frame: Baseline, month 6

Change in HbA1c (glycosylated haemoglobin)

Time frame: Baseline, month 6

Change in Fasting blood glucose (FBG)

Time frame: Baseline, month 6

Change in body weight

Time frame: Baseline, month 6

Hypoglycaemic episodes

Time frame: Month 6

Adverse events

Time frame: Month 6

Data from ClinicalTrials.gov

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