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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01542476
First received: February 24, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Patient-Reported Outcomes (PRO) using Insulin Treatment (ITSQ) [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
  • Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
  • Change in Fasting blood glucose (FBG) [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542476

Locations
Netherlands
Alphen a/d Rijn, Netherlands
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Helene Philippo Novo Nordisk B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01542476     History of Changes
Other Study ID Numbers: NN304-1924
Study First Received: February 24, 2012
Last Updated: February 24, 2012
Health Authority: Netherlands: Dutch Health Care Inspectorate

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

ClinicalTrials.gov processed this record on August 21, 2014