An Observational Study in Dutch Type 1 and Type 2 Diabetes Patients: The Impact of Initiation of/Switching to Levemir® on Emotional Well-being, Insulin Perceptions and Treatment Satisfaction - CONFIDENCE (Clinical ObservatioNs oF Levemir® In Dutch ExperieNCE)

Novo Nordisk A/S0 sites299 target enrollmentAugust 2006

ConditionsDiabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventionsinsulin detemir

Drugsinsulin detemir

Overview

Phase: Not Applicable
Intervention: insulin detemir
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 299
Primary Endpoint: Change in Patient-Reported Outcomes (PRO) using World Health Organization 5 (WHO-5) item Well-being Index: Insulin Treatment Appraisal Scale (ITAS)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2006

End Date

October 2007

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

IDet users

Intervention: insulin detemir

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

Hypoglycaemic episodes(Month 6)
Adverse events(Month 6)
Change in Fasting blood glucose (FBG)(Baseline, month 6)
Change in body weight(Baseline, month 6)
Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ)(Baseline, month 6)
Change in HbA1c (glycosylated haemoglobin)(Baseline, month 6)