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OpenTrials
Completed

NCT Number: NCT00704574

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

insulin detemir

Drug

No extra intervention, only normal clinical practise for treatment of type 1 diabetes

Other names: Levemir®

Primary outcomes

  1. Incidence of serious adverse drug reactions, including major hypoglycaemic events

    Time frame: after 6 month treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety of Levemir® (Insulin Detemir) Treatment in Children and Adolescents With Type 1 Diabetes (PREDICTIVE™ - Youth)

Acronym: PREDICTIVE™

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2008
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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