Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Interventions
- 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
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
Exclusion Criteria
Not provided
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 HbA1c (glycosylated haemoglobin) Blood glucose level at each time-point in the 8-point glucose profile BMI (Body Mass Index)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of biphasic insulin aspart 30 in managing type 1 diabetes in juveniles?
How does biphasic insulin aspart 30 compare to other basal-bolus insulin regimens in pediatric type 1 diabetes patients?
What biomarkers are associated with improved glycemic control in type 1 diabetes patients using BIAsp 30?
What are the long-term adverse events reported in clinical trials of biphasic insulin aspart 30 for juvenile type 1 diabetes?
Are there combination therapies involving biphasic insulin aspart 30 and GLP-1 receptor agonists for type 1 diabetes management?
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇿🇦Cape Town, Western Cape, South Africa
Novo Nordisk Investigational Site🇿🇦Cape Town, Western Cape, South Africa