Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00564668
First received: November 27, 2007
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 24-week, Randomised, Multi-centre, Double-blind, Parallel-group Trial to Investigate the Safety and the Efficacy of NN2000-Mix30 Compared to NN-X14Mix30 NovoRapid®30Mix) in Subjects With Type 2 Diabetes Mellitus on a Twice Daily Regimen

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety [ Time Frame: During 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: June 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • Subjects with insulin treatment for at least 24 weeks
  • Current treatment with premixed biphasic human insulin preparation for at least 12 weeks
  • HbA1c lesser than or equal to 11.0%

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Impaired renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Subjects with known malignant tumour
  • Total daily insulin dose greater than or equal to 100 IU
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564668

Locations
Japan
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Michiaki Kanai, MSc Novo Nordisk Pharma Ltd.
Study Director: Akira Matsutani Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00564668     History of Changes
Other Study ID Numbers: NN2000-1611
Study First Received: November 27, 2007
Last Updated: November 21, 2013
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014