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OpenTrials
Completed

NCT Number: NCT01486381

Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes

This trial is conducted in South Africa. The aim of this trial is to investigate Long term safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in trial BIAsp-1240.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Pretoria, Gauteng, South Africa

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent obtained before any trial-related activities according to local requirements. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • The subject must have completed the trial BIAsp-1240

Treatment and study plan

biphasic insulin aspart 30

Drug

Administered subcutaneously (s.c., under the skin)

Primary outcomes

  1. Number of hypoglycaemic episodes

  2. Occurence of adverse events

  3. Standard safety parameters: Haematology, biochemistry and vital signs

Secondary outcomes

  1. HbA1c (glycosylated haemoglobin)

  2. Blood glucose level at each time-point in the 8-point glucose profile

  3. BMI (Body Mass Index)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-national, Multi-centre, Open-labelled Extension Study Assessing the Long-term Safety of Biphasic Insulin Aspart 30 (BIAsp 30) in Young Diabetic Subjects With Type 1 Diabetes Mellitus Previously Treated in BIAsp-1240

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Dec 6, 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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