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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01527539
First Posted: February 7, 2012
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 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: None (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

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)

  Eligibility

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
Criteria

Inclusion Criteria:

  • Completed the BIAsp-1237 trial
  Contacts and Locations
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): NCT01527539


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01527539     History of Changes
Other Study ID Numbers: BIASP-1479
First Submitted: February 2, 2012
First Posted: February 7, 2012
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
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs