Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01467375
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
Inclusion Criteria
- Subjects must have been correctly included in and completed BIAsp-1234
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A biphasic insulin aspart -
- Primary Outcome Measures
Name Time Method Frequency of hypoglycaemic episodes Occurrence of adverse events
- Secondary Outcome Measures
Name Time Method HbA1c (glycosylated haemoglobin)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇦Saskatoon, Canada