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Observational Study of the Predictability of Levemir® in Terms of Metabolic Control, Change of Body Weight and Hypos

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01542489
First received: February 24, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational 3 Months Study to Evaluate the Effect of Insulin Levemir® on Glycaemic Control, Weight and Incidence of Hypoglycaemic Events in Insulin Treated Subjects With Type 1 or Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in 7-point blood glucose variability [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]
  • Insulin dose [ Designated as safety issue: No ]
  • Number of injections [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Number of adverse events [ Designated as safety issue: No ]

Enrollment: 480
Study Start Date: October 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IDet + IAsp 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
Drug: insulin aspart
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
IDet + HI 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
Drug: human soluble insulin
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 treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue Levemir® in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)

Criteria

Inclusion Criteria:

  • Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542489

Locations
Slovakia
Bratislava, Slovakia, 811 05
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: M. Suplatova Novo Nordisk Slovakia s.r.o.
  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: NCT01542489     History of Changes
Other Study ID Numbers: NN304-1927
Study First Received: February 24, 2012
Last Updated: February 24, 2012
Health Authority: Slovakia: State Institute for Drug Control

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 aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013