NCT01486381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Mar 2002

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2002

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2003

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

November 22, 2011

Last Update Submit

February 22, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

  • Number of hypoglycaemic episodes

  • Occurence of adverse events

  • Standard safety parameters: Haematology, biochemistry and vital signs

Secondary Outcomes (3)

  • HbA1c (glycosylated haemoglobin)

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

  • BMI (Body Mass Index)

Study Arms (1)

BIAsp 30

EXPERIMENTAL
Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

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

BIAsp 30

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

Pretoria, Gauteng, 0001, South Africa

Location

Novo Nordisk Investigational Site

Cape Town, Western Cape, 7925, South Africa

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

December 6, 2011

Study Start

March 20, 2002

Primary Completion

May 30, 2003

Study Completion

May 30, 2003

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

ZA(2)