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

This study has been completed.
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: February 2, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
This trial is conducted in North America. The aim of this trial is asses the long term safety and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes who had participated in the BIAsp-1237 trial.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre, Non-comparative, Open-labelled, Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes (Extension to BIAsp-1237)

Resource links provided by NLM:

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

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

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

Enrollment: 25
Study Start Date: November 2001
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp 30 Drug: biphasic insulin aspart 30
Dose individually adjusted. Injected twice daily immediately before breakfast and dinner. Administrated subcutaneously (s.c., under the skin)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Completed the BIAsp-1237 trial
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01527539

Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Toronto, Ontario, Canada, M5B 1W8
Windsor, Canada, N8W 3K2
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Paul Williamson Novo Nordisk Canada Inc.
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01527539     History of Changes
Other Study ID Numbers: BIASP-1479 
Study First Received: February 2, 2012
Last Updated: February 2, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 26, 2016