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Observational Study to Observe the Safety of Levemir® Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™)

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. Identifier: NCT00704574
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This observational study is conducted in Europe. The trial aims to observe the incidence of serious adverse drug reactions in children and adolescents with type 1 diabetes during Levemir® treatment.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir

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Study Type : Observational
Actual Enrollment : 159 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™ - Youth)
Study Start Date : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
A Drug: insulin detemir
No extra intervention, only normal clinical practise for treatment of type 1 diabetes
Other Name: Levemir®

Primary Outcome Measures :
  1. Incidence of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: after 6 month treatment ]

Secondary Outcome Measures :
  1. Number of all hypoglycaemic events [ Time Frame: after 6 month treatment ]
  2. Number of adverse drug reactions [ Time Frame: after 6 month treatment ]
  3. BMI changes [ Time Frame: after 6 month treatment ]
  4. HbA1c [ Time Frame: after 6 month treatment ]
  5. Variability in FPG (Fasting Plasma Glucose) [ Time Frame: after 6 month treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children Age 6 - 18 with type 1 diabetes

Inclusion Criteria:

  • Informed consent obtained prior to any trial-related activities
  • Any patient with diabetes type 1 is eligible for the study, including newly
  • The selection of the patients will be at the discretion of the individual physician

Exclusion Criteria:

  • Type 2 diabetes
  • Currently treated with Levemir®

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 identifier (NCT number): NCT00704574

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Novo Nordisk Investigational Site
Lund, Sweden, 221 85
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00704574     History of Changes
Other Study ID Numbers: NN304-1920
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs