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Completed

NCT Number: NCT01467375

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Broadmeadow, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart

Drug

Individually adjusted dose, injected s.c. (under the skin) before breakfast and dinner

Primary outcomes

  1. Occurrence of adverse events

  2. Frequency of hypoglycaemic episodes

Secondary outcomes

  1. HbA1c (glycosylated haemoglobin)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Nov 8, 2011
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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