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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01467375
First received: November 4, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted

November 4, 2011
November 4, 2011
January 2001
October 2004   (final data collection date for primary outcome measure)
  • Occurrence of adverse events [ Designated as safety issue: No ]
  • Frequency of hypoglycaemic episodes [ Designated as safety issue: No ]
Same as current
No Changes Posted
HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes
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

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Individually adjusted dose, injected s.c. (under the skin) before breakfast and dinner
Experimental: A
Intervention: Drug: biphasic insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
October 2004
October 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada
 
NCT01467375
BIASP-1361
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Jean-Marc Tellier Novo Nordisk Canada Inc.
Novo Nordisk
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP