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OpenTrials
Completed

NCT Number: NCT00604656

Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with type 1 diabetes
  • Duration of diabetes for at least 12 months
  • Treatment with insulin aspart for at least 3 months before trial start
  • Body Mass Index (BMI) below 35.0 kg/m2
  • HbA1c below 12.0%

Exclusion criteria

  • Total insulin dosage more than 1.4 IU/kg/day
  • Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
  • Known hypoglycaemia unawareness as judged by the investigator
  • Known hypersensitivity or allergy

Treatment and study plan

insulin aspart

Drug

Primary outcomes

  1. Insulin aspart antibodies

    Time frame: After 6 months treatment

Secondary outcomes

  1. Occurrence of adverse events

  2. Incidence of hypoglycaemic episodes

  3. HbA1c

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on a Basal/Bolus Regimen

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jan 30, 2008
Registry last updated
Mar 1, 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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