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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
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013