Clinical trial NCT00604656: Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
Official title: A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on 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: 2008-01-30
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 1 diabetes
* Duration of diabetes for at least 12 months
* Treatment with insulin aspart for at least 3 months before trial start
* Body Mass Index (BMI) below 35.0 kg/m2
* HbA1c below 12.0%

Exclusion Criteria:

* Total insulin dosage more than 1.4 IU/kg/day
* Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
* Known hypoglycaemia unawareness as judged by the investigator
* Known hypersensitivity or allergy

Primary outcomes:
measure: Insulin aspart antibodies
timeFrame: After 6 months treatment
Secondary outcomes:
measure: Occurrence of adverse events
measure: Incidence of hypoglycaemic episodes
measure: HbA1c
Other outcomes:
Locations:
city: Hradec Králové
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha 5
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Bad Kreuznach
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Neuenahr-Ahrweiler
country: Germany
facility: Novo Nordisk Investigational Site
city: Diez
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Karlsruhe
country: Germany
facility: Novo Nordisk Investigational Site
city: Marktheidenfeld
country: Germany
facility: Novo Nordisk Investigational Site
city: Marl
country: Germany
facility: Novo Nordisk Investigational Site
city: Oberursel
country: Germany
facility: Novo Nordisk Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Saarbrücken
country: Germany
facility: Novo Nordisk Investigational Site
city: Simmern
country: Germany
facility: Novo Nordisk Investigational Site
city: Speyer
country: Germany
facility: Novo Nordisk Investigational Site
city: St. Ingbert
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Nyíregyháza
country: Hungary
facility: Novo Nordisk Investigational Site
city: Cagliari
country: Italy
facility: Novo Nordisk Investigational Site
city: Chiavari
country: Italy
facility: Novo Nordisk Investigational Site
city: Citta' Di Castello
country: Italy
facility: Novo Nordisk Investigational Site
city: Lucca
country: Italy
facility: Novo Nordisk Investigational Site
city: Orvieto
country: Italy
facility: Novo Nordisk Investigational Site
city: Parma
country: Italy
facility: Novo Nordisk Investigational Site
city: Perugia
country: Italy
facility: Novo Nordisk Investigational Site
city: Rimini
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Bytom
country: Poland
facility: Novo Nordisk Investigational Site
city: Mazowieckie
country: Poland
facility: Novo Nordisk Investigational Site
city: Radom
country: Poland
facility: Novo Nordisk Investigational Site
city: Warsaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: