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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604656
First Posted: January 30, 2008
Last Update Posted: March 1, 2017
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.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 Diabetes Mellitus, Type 1 Drug: insulin aspart Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date: May 5, 2003
Study Completion Date: January 29, 2004
Primary Completion Date: January 29, 2004 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00604656


Locations
Czech Republic
Novo Nordisk Investigational Site
Hradec Králové, Czech Republic, 500 36
Novo Nordisk Investigational Site
Praha 5, Czech Republic, 15018
Germany
Novo Nordisk Investigational Site
Bad Kreuznach, Germany, 55545
Novo Nordisk Investigational Site
Bad Neuenahr-Ahrweiler, Germany, 53474
Novo Nordisk Investigational Site
Diez, Germany, 65582
Novo Nordisk Investigational Site
Frankfurt, Germany, 60325
Novo Nordisk Investigational Site
Friedrichsthal, Germany, 66299
Novo Nordisk Investigational Site
Karlsruhe, Germany, 76133
Novo Nordisk Investigational Site
Marktheidenfeld, Germany, 97828
Novo Nordisk Investigational Site
Marl, Germany, 45770
Novo Nordisk Investigational Site
Oberursel, Germany, 61440
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
Saarbrücken, Germany, 66121
Novo Nordisk Investigational Site
Simmern, Germany, 55469
Novo Nordisk Investigational Site
Speyer, Germany, 67346
Novo Nordisk Investigational Site
St. Ingbert, Germany, 66386
Novo Nordisk Investigational Site
Würzburg, Germany, 97072
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1096
Novo Nordisk Investigational Site
Nyíregyháza, Hungary, 4400
Italy
Novo Nordisk Investigational Site
Cagliari, Italy, 09124
Novo Nordisk Investigational Site
Chiavari, Italy, 16043
Novo Nordisk Investigational Site
Citta' Di Castello, Italy, 06012
Novo Nordisk Investigational Site
Lucca, Italy, 55100
Novo Nordisk Investigational Site
Orvieto, Italy, 05018
Novo Nordisk Investigational Site
Parma, Italy, 43100
Novo Nordisk Investigational Site
Perugia, Italy, 06126
Novo Nordisk Investigational Site
Rimini, Italy, 47900
Novo Nordisk Investigational Site
Roma, Italy, 00128
Novo Nordisk Investigational Site
Roma, Italy, 00133
Poland
Novo Nordisk Investigational Site
Bytom, Poland, 41-902
Novo Nordisk Investigational Site
Mazowieckie, Poland, 09-400
Novo Nordisk Investigational Site
Radom, Poland, 26-600
Novo Nordisk Investigational Site
Warsaw, Poland, 03-242
Novo Nordisk Investigational Site
Wroclaw, Poland, 50-306
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00604656     History of Changes
Other Study ID Numbers: NN2000-1542
First Submitted: January 17, 2008
First Posted: January 30, 2008
Last Update Posted: March 1, 2017
Last Verified: February 2017

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
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs