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

Diabetes Mellitus, Type 2 Clinical Trial

— CONFIDENCE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542476
• Other study ID #: NN304-1924
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: March 2, 2016
• Start date: August 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care Inspectorate
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ)		Baseline, month 6	No
Secondary	Change in HbA1c (glycosylated haemoglobin)		Baseline, month 6	No
Secondary	Change in Fasting blood glucose (FBG)		Baseline, month 6	No
Secondary	Change in body weight		Baseline, month 6	No
Secondary	Hypoglycaemic episodes		Month 6	No
Secondary	Adverse events		Month 6	No

External Links

•   Clinical Trials at Novo Nordisk