Clinical trial NCT01520818: Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes
Official title: A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 666
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 compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.


Eligibility criteria: Inclusion Criteria:

* Type 1 or Type 2 diabetes
* Current treatment with BHI 30 twice daily as the only insulin therapy for at least 3 months, with or without combination with oral hypoglycaemic agents
* Body mass index (BMI) maximum 40.0 kg/m\^2

Exclusion Criteria:

* History of drug or alcohol dependence
* Impaired hepatic function
* Impaired renal function
* Cardiac disease
* Proliferative retinopathy
* Total daily insulin dose at least 1.80 IU/kg

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin A1c)
Secondary outcomes:
measure: Blood glucose profiles
measure: Adverse events
measure: Hypoglycaemic episodes
measure: Quality of Life (QoL) assessed via World Health Organization Diabetes Treatment Satisfaction Questionnaire (WHO DTSQ)
measure: Quality of Life (QoL) assessed via Diabetes Health Profile (DHP-2)
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Novo Nordisk Investigational Site
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Edegem
country: Belgium
facility: Novo Nordisk Investigational Site
city: Genk
country: Belgium
facility: Novo Nordisk Investigational Site
city: Jumet
country: Belgium
facility: Novo Nordisk Investigational Site
city: Liège
country: Belgium
facility: Novo Nordisk Investigational Site
city: Amiens
country: France
facility: Novo Nordisk Investigational Site
city: Avignon
country: France
facility: Novo Nordisk Investigational Site
city: Bagnols-sur-ceze
country: France
facility: Novo Nordisk Investigational Site
city: Bordeaux
country: France
facility: Novo Nordisk Investigational Site
city: Caen
country: France
facility: Novo Nordisk Investigational Site
city: Colmar
country: France
facility: Novo Nordisk Investigational Site
city: DIJON cedex
country: France
facility: Novo Nordisk Investigational Site
city: Dommartin Les Toul
country: France
facility: Novo Nordisk Investigational Site
city: GRENOBLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Le Creusot
country: France
facility: Novo Nordisk Investigational Site
city: Lorient
country: France
facility: Novo Nordisk Investigational Site
city: Lyon
country: France
facility: Novo Nordisk Investigational Site
city: Macon
country: France
facility: Novo Nordisk Investigational Site
city: Marseille
country: France
facility: Novo Nordisk Investigational Site
city: Nanterre
country: France
facility: Novo Nordisk Investigational Site
city: Narbonne
country: France
facility: Novo Nordisk Investigational Site
city: NEVERS cedex
country: France
facility: Novo Nordisk Investigational Site
city: Nimes
country: France
facility: Novo Nordisk Investigational Site
city: Orleans
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: Reims
country: France
facility: Novo Nordisk Investigational Site
city: Roubaix
country: France
facility: Novo Nordisk Investigational Site
city: Saint Etienne
country: France
facility: Novo Nordisk Investigational Site
city: Strasbourg
country: France
facility: Novo Nordisk Investigational Site
city: TOULOUSE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Dublin
country: Ireland
facility: Novo Nordisk Investigational Site
city: Alkmaar
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Amersfoort
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Arnhem
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Beverwijk
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Delft
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Bosch
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Haag
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Einhoven
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Hengelo
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Ayrsh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Ayr
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Birmingham
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: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edgware
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Exeter
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Haywards Heath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Ipswich
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leeds
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Paisley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Poole
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Rugby
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Scunthorpe
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Southampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sunderland
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Watford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Whiston
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: Clements MR, Tits J, Kinsley BT, Rastam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x.