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Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01467375
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the BIAsp-1234 trial.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Non Comparative, Multicentre Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Who Have Completed BIAsp-1234
Actual Study Start Date : January 8, 2001
Primary Completion Date : October 22, 2004
Study Completion Date : October 22, 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: biphasic insulin aspart
Individually adjusted dose, injected s.c. (under the skin) before breakfast and dinner

Primary Outcome Measures :
  1. Occurrence of adverse events
  2. Frequency of hypoglycaemic episodes

Secondary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin)

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subjects must have been correctly included in and completed BIAsp-1234

Exclusion Criteria:

  • Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial
  • Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-1234.
  • Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods)
  • Known or suspected allergy to trial product or related products
  • Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease

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): NCT01467375

Australia, New South Wales
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, Australia, 2292
Australia, Victoria
Novo Nordisk Investigational Site
Parkville, Victoria, Australia, 3052
Novo Nordisk Investigational Site
Ashford, Australia, 5035
Novo Nordisk Investigational Site
Auchenflower, Australia, 4066
Novo Nordisk Investigational Site
Launceston, Australia, 7250
Novo Nordisk Investigational Site
Nowra, Australia, 2540
Novo Nordisk Investigational Site
Ringwood, Australia, 3134
Novo Nordisk Investigational Site
Rooty Hill, Australia, 2766
Novo Nordisk Investigational Site
Hull, Canada, J8Y 1W1
Novo Nordisk Investigational Site
London, Canada, N6A 4L6
Novo Nordisk Investigational Site
Quebec, Canada, G1V 4G2
Novo Nordisk Investigational Site
Saskatoon, Canada, S7N 0W8
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01467375     History of Changes
Other Study ID Numbers: BIASP-1361
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs