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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00604656
First received: January 17, 2008
Last updated: November 21, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of adverse events [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • HbA1c [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00604656

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00604656     History of Changes
Other Study ID Numbers: NN2000-1542
Study First Received: January 17, 2008
Last Updated: November 21, 2013
Health Authority: Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health and Social Security
Italy: National Institute of Health
Hungary: Ministry of Health, Social and Family Affairs

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
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014