Clinical trial NCT01704378: Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes
Official title: A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-11
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities
* Completed the trial BIAsp-1236

Exclusion Criteria:

* Planned changes in use of any prescription medication that may interfere with glucose regulation
* Known or suspected allergy to trial products or related products
* Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
* Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator

Primary outcomes:
measure: Number of Hypoglycaemic episodes
measure: Occurrence of adverse events
Secondary outcomes:
measure: HbA1c (glycosylated haemoglobin)
measure: Prandial increment in blood glucose
measure: 7-point blood glucose profile
Other outcomes:
Locations:
city: Kotka
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuopio
country: Finland
facility: Novo Nordisk Investigational Site
city: Lahti
country: Finland
facility: Novo Nordisk Investigational Site
city: Gjøvik
country: Norway
facility: Novo Nordisk Investigational Site
city: Horten
country: Norway
facility: Novo Nordisk Investigational Site
city: Kirkenær
country: Norway
facility: Novo Nordisk Investigational Site
city: Kongsvinger
country: Norway
facility: Novo Nordisk Investigational Site
city: Notodden
country: Norway
facility: Novo Nordisk Investigational Site
city: Falun
country: Sweden
facility: Novo Nordisk Investigational Site
city: Helsingborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Motala
country: Sweden
facility: Novo Nordisk Investigational Site
city: Derby
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hull
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Liverpool
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Scarborough
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wirral, Merseyside
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: