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

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT01486381
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03-20
• Primary Completion: 2003-05-30
• Study Completion: 2003-05-30
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIAsp 30	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Number of hypoglycaemic episodes
Occurence of adverse events
Standard safety parameters: Haematology, biochemistry and vital signs

Secondary Outcome Measures

Name	Time	Method
Blood glucose level at each time-point in the 8-point glucose profile
BMI (Body Mass Index)
HbA1c (glycosylated haemoglobin)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇿🇦 Cape Town, Western Cape, South Africa