Clinical trial NCT01467401: Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes
Official title: A Multi-National, Multi-Centre, Randomised, Open-Labelled, Parallel Trial Comparing Efficacy and Safety of NovoMix® 30 FlexPen® and Mixtard® 30 Twice Daily Injections in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 292
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 efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 24 months
* Insulin treatment for the pase 3 months
* HbA1c (glycosylated haemoglobin) below 13%
* BMI (Body Mass Index) below 40 kg/m\^2
* Ability and willingness to perform self-blood glucose monitoring

Exclusion Criteria:

* Receipt of any investigational drug within 4 weeks prior to this trial
* Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
* Total daily insulin dosage less than or equal to 1.8 IU/kg

Primary outcomes:
measure: HbA1c (glycolated haemoglobin)
Secondary outcomes:
measure: Prandial increment in blood glucose
measure: 7-point blood glucose profile
measure: Number and severity of adverse events
measure: Number and severity of local tolerability issues at the injection site
measure: Number and severity of hypoglycaemic episodes
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Herning
country: Denmark
facility: Novo Nordisk Investigational Site
city: Holbæk
country: Denmark
facility: Novo Nordisk Investigational Site
city: Næstved
country: Denmark
facility: Novo Nordisk Investigational Site
city: Randers
country: Denmark
facility: Novo Nordisk Investigational Site
city: Silkeborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Skive
country: Denmark
facility: Novo Nordisk Investigational Site
city: Viborg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Bekkestua
country: Norway
facility: Novo Nordisk Investigational Site
city: Bergen
country: Norway
facility: Novo Nordisk Investigational Site
city: Haugesund
country: Norway
facility: Novo Nordisk Investigational Site
city: Hønefoss
country: Norway
facility: Novo Nordisk Investigational Site
city: Moelv
country: Norway
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Tromsø
country: Norway
facility: Novo Nordisk Investigational Site
city: Vennesla
country: Norway
facility: Novo Nordisk Investigational Site
city: Åsgårdstrand
country: Norway
facility: Novo Nordisk Investigational Site
city: Arvika
country: Sweden
facility: Novo Nordisk Investigational Site
city: Avesta
country: Sweden
facility: Novo Nordisk Investigational Site
city: Bjuv
country: Sweden
facility: Novo Nordisk Investigational Site
city: Broby
country: Sweden
facility: Novo Nordisk Investigational Site
city: Färgelanda
country: Sweden
facility: Novo Nordisk Investigational Site
city: Grästorp
country: Sweden
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Habo
country: Sweden
facility: Novo Nordisk Investigational Site
city: Helsingborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Härnösand
country: Sweden
facility: Novo Nordisk Investigational Site
city: Hässleholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Jönköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Karlstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Karlstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Kristianstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Kristinehamn
country: Sweden
facility: Novo Nordisk Investigational Site
city: Kungsbacka
country: Sweden
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Mellerud
country: Sweden
facility: Novo Nordisk Investigational Site
city: Mölndal
country: Sweden
facility: Novo Nordisk Investigational Site
city: Norrköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Skövde
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Säffle
country: Sweden
facility: Novo Nordisk Investigational Site
city: Tomelilla
country: Sweden
facility: Novo Nordisk Investigational Site
city: Torsby
country: Sweden
facility: Novo Nordisk Investigational Site
city: Trollhättan
country: Sweden
facility: Novo Nordisk Investigational Site
city: Trollhättan
country: Sweden
facility: Novo Nordisk Investigational Site
city: Tyresö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uddevalla
country: Sweden
facility: Novo Nordisk Investigational Site
city: Värnamo
country: Sweden
facility: Novo Nordisk Investigational Site
city: Örebro
country: Sweden
facility: Novo Nordisk Investigational Site
city: Örebro
country: Sweden
facility: Novo Nordisk Investigational Site
city: Örebro
country: Sweden
facility: Novo Nordisk Investigational Site
city: Östersund
country: Sweden
facility: Novo Nordisk Investigational Site
city: Östersund
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: