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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: January 17, 2008
Last updated: November 21, 2013
Last verified: November 2013
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.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Insulin aspart antibodies [ Time Frame: After 6 months treatment ]

Secondary Outcome Measures:
  • Occurrence of adverse events
  • Incidence of hypoglycaemic episodes
  • HbA1c

Enrollment: 241
Study Start Date: May 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00604656

Czech Republic
Praha 5, Czech Republic, 15018
Frankfurt, Germany, 60325
Budapest, Hungary, 1096
Nyiregyhaza, Hungary, 4400
Perugia, Italy, 06126
Bytom, Poland, 41-902
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Karsten Lyby, MSc Novo Nordisk A/S
  More Information

Additional Information: Identifier: NCT00604656     History of Changes
Other Study ID Numbers: NN2000-1542 
Study First Received: January 17, 2008
Last Updated: November 21, 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on February 20, 2017