Clinical trial NCT00600626: Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes
Official title: Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-25
Enrollment: 394
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 Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
* HbA1c between 8.0-10.5%
* Body mass index (BMI) below 35.0 kg/m2
* Able and willing to perform self-monitoring of blood glucose

Exclusion Criteria:

* Total daily insulin dose of 1.80 IU/kg or more
* Known or suspected allergy to trial product or related products
* Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

Primary outcomes:
measure: HbA1c
timeFrame: after 4 months of treatment
Secondary outcomes:
measure: 8-point blood glucose profile
measure: incidence of hypoglycaemic episodes
measure: safety profiles
measure: changes in body weight and vital signs
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: NEVERS cedex
country: France
facility: Novo Nordisk Investigational Site
city: Rennes
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Bad Heilbrunn
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
city: Schaafheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Schwedt
country: Germany
facility: Novo Nordisk Investigational Site
city: St. Ingbert
country: Germany
facility: Novo Nordisk Investigational Site
city: Völklingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Wiesbaden
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Shatin, New Territories
country: Hong Kong
facility: Novo Nordisk Investigational Site
city: Cheras
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kota Bharu, Kelantan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Beverwijk
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Delft
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Eindhoven
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
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: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Zabrze
country: Poland
facility: Novo Nordisk Investigational Site
city: Cluj Napoca
country: Romania
facility: Novo Nordisk Investigational Site
state: Cluj
city: Constanta
country: Romania
facility: Novo Nordisk Investigational Site
city: Iasi
country: Romania
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: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Orihuela
country: Spain
facility: Novo Nordisk Investigational Site
city: Sabadell
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valladolid
country: Spain
facility: Novo Nordisk Investigational Site
city: Falun
country: Sweden
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
city: Mölndal
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uppsala
country: Sweden
facility: Novo Nordisk Investigational Site
city: Bradford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Brighton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Coventry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Northampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: York
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:
citation: Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9. doi: 10.1055/s-2006-924424.