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Completed

NCT Number: NCT00872560

Comparison of 2 NovoFine® Needles on the Reflux of Insulin

This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.

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Key information

Conditions

Diabetes Autoimmune Diseases Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

Chieti, 66100, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children/adolescents with type 1 diabetes mellitus
  • Usage of NovoPen® 1.5 for at least 3 months
  • Duration of insulin treatment more than 1 year
  • Normal weight according to Tanner scales
  • The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%

Exclusion criteria

  • Pregnancy or desire to become pregnant
  • Clinical relevant peripheral neuropathy as judged by the investigators
  • Pronounced lipodystrophy in accordance with investigator's evaluation
  • Use of drugs that can influence the trial
  • Coagulation disorders (use of anti-coagulants)
  • Serious, chronic diseases, making it highly unlikely that the subject can complete the trial

Treatment and study plan

NovoFine® needle 6 mm

Device

Other names: NEEDLEN

NovoFine® needle 8 mm

Device

Other names: NEEDLEN

Primary outcomes

  1. Weighing of reflux of insulin

    Time frame: 6 seconds after injection

Secondary outcomes

  1. Pain perception

    Time frame: after 6 weeks of treatment

  2. Number and severity of bleedings

    Time frame: after 6 weeks of treatment

  3. Reactions at injection sites

    Time frame: after 6 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres

Important dates

Study start
1998
Primary completion
1998
Study completion
1998
First posted
Mar 31, 2009
Registry last updated
Aug 7, 2018

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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