We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542476
First Posted: March 2, 2012
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 299
Study Start Date: August 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IDet users 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any subject with type 1 or type 2 diabetes not optimally controlled 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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542476


Locations
Netherlands
Alphen a/d Rijn, Netherlands
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01542476     History of Changes
Other Study ID Numbers: NN304-1924
First Submitted: February 24, 2012
First Posted: March 2, 2012
Last Update Posted: March 3, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs