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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: February 2, 2012
Last updated: February 22, 2017
Last verified: February 2017
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
Intervention Model: Single Group Assignment
Masking: No masking
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

Secondary Outcome Measures:
  • Occurrence of adverse events
  • Occurence of hypoglycaemic episodes

Enrollment: 25
Actual Study Start Date: November 23, 2001
Study Completion Date: October 12, 2004
Primary Completion Date: October 12, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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 identifier: NCT01527539

Canada, Nova Scotia
Novo Nordisk Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M5B 1W8
Novo Nordisk Investigational Site
Edmonton, Canada, T5H 3V9
Novo Nordisk Investigational Site
Windsor, Canada, N8W 3K2
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01527539     History of Changes
Other Study ID Numbers: BIASP-1479
Study First Received: February 2, 2012
Last Updated: February 22, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin, Isophane
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 22, 2017