Clinical trial NCT00832182: Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes
Official title: An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/065 trial


Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
* The subject must have completed the ANA/DCD/065 trial

Exclusion Criteria:

* Impaired hepatic function
* Impaired renal function
* Total daily insulin requirements of more than 1.4 U/kg
* Cardiac problems
* Uncontrolled hypertension
* Known or suspected allergy to trial product or related products
* Current hypoglycaemic unawareness as judged by the investigator
* Known or suspect abuse of alcohol or narcotics
* Women breastfeeding or having the intention of becoming pregnant, or if judged not to be using adequate contraceptive measures (adequate measures are intrauterine device (IUD), oral contraception and barrier methods)
* Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results

Primary outcomes:
measure: Number of hypoglycemic episodes and adverse events
timeFrame: at 3 and 6 months and at the end of the trial
Secondary outcomes:
measure: HbA1c
timeFrame: at 3 and 6 months and at the end of the trial
measure: 9-point blood glucose profile
timeFrame: at 3 and 6 months and at the end of the trial
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Praha 10
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha 2
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Tel Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Cada DJ, Levien T, Baker DE. Insulin aspart. Hospital Pharmacy 2000; 35: 1221-1229