Clinical trial NCT01486940: Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes
Official title: A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin 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: 2011-12-07
Enrollment: 598
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 and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
* BMI below or equal to 35 kg/m\^2
* HbA1c below or equal to 12%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment
* Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
* Subjects with known hypoglycaemic unawareness as judged by the Investigator

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
measure: 8-point blood glucose profiles
measure: Incidence of self-recorded hypoglycaemic episodes
measure: Incidence of adverse events
Other outcomes:
Locations:
city: Junin
country: Argentina
facility: Novo Nordisk Investigational Site
city: Moron
country: Argentina
facility: Novo Nordisk Investigational Site
city: Varazdin
country: Croatia
facility: Novo Nordisk Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Liberec
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Plzen - Lochotin
country: Czech Republic
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: Praha 4
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Praha 5
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Hillerød
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hjørring
country: Denmark
facility: Novo Nordisk Investigational Site
city: Holbæk
country: Denmark
facility: Novo Nordisk Investigational Site
city: København
country: Denmark
facility: Novo Nordisk Investigational Site
city: Køge
country: Denmark
facility: Novo Nordisk Investigational Site
city: Silkeborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Slagelse
country: Denmark
facility: Novo Nordisk Investigational Site
city: Svendborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Kemi
country: Finland
facility: Novo Nordisk Investigational Site
city: Kokkola
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuopio
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Pärnu
country: Finland
facility: Novo Nordisk Investigational Site
city: Rovaniemi
country: Finland
facility: Novo Nordisk Investigational Site
city: Viljandi
country: Finland
facility: Novo Nordisk Investigational Site
city: Angers
country: France
facility: Novo Nordisk Investigational Site
city: GRENOBLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: Lorient
country: France
facility: Novo Nordisk Investigational Site
city: MONTPELLIER cedex 5
country: France
facility: Novo Nordisk Investigational Site
city: Mougins
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: Paris Cedex 10
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Poitiers
country: France
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Alessandria
country: Italy
facility: Novo Nordisk Investigational Site
city: Asti
country: Italy
facility: Novo Nordisk Investigational Site
city: Bari
country: Italy
facility: Novo Nordisk Investigational Site
city: Bergamo
country: Italy
facility: Novo Nordisk Investigational Site
city: Catania
country: Italy
facility: Novo Nordisk Investigational Site
city: Catania
country: Italy
facility: Novo Nordisk Investigational Site
city: Genova
country: Italy
facility: Novo Nordisk Investigational Site
city: Lucca
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Padova
country: Italy
facility: Novo Nordisk Investigational Site
city: Prato
country: Italy
facility: Novo Nordisk Investigational Site
city: Ravenna
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Torino
country: Italy
facility: Novo Nordisk Investigational Site
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Novo Nordisk Investigational Site
city: Arendal
country: Norway
facility: Novo Nordisk Investigational Site
city: Gjettum
country: Norway
facility: Novo Nordisk Investigational Site
city: Gjøvik
country: Norway
facility: Novo Nordisk Investigational Site
city: Kongsberg
country: Norway
facility: Novo Nordisk Investigational Site
city: Kongsvinger
country: Norway
facility: Novo Nordisk Investigational Site
city: Kristiansand S
country: Norway
facility: Novo Nordisk Investigational Site
city: Rådal
country: Norway
facility: Novo Nordisk Investigational Site
city: Bydgoszcz
country: Poland
facility: Novo Nordisk Investigational Site
city: Bydgoszcz
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Krakow
country: Poland
facility: Novo Nordisk Investigational Site
city: Lodz
country: Poland
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Szczecin
country: Poland
facility: Novo Nordisk Investigational Site
city: Timisoara
country: Romania
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: Kosice
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Moldava nad Bodvou
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Falun
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia. 2004 Apr;47(4):622-9. doi: 10.1007/s00125-004-1365-z.