Clinical trial NCT03220425: Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.
Official title: A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent obtained before any trial-related activities
* Type 1 diabetes diagnosed and classified according to aetiology
* Duration of type 1 diabetes equal to or more than 12 months
* Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
* Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

* Proliferative retinopathy
* Total basal insulin dose of more than 100 IU per day
* Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
* Known unawareness of hypoglycaemia
* Previous treatment with insulin detemir

Primary outcomes:
measure: The change in the level of glycosylated haemoglobin(HbA1c)
timeFrame: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)
Secondary outcomes:
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Ashford
country: Australia
facility: Novo Nordisk Investigational Site
city: Box Hill
country: Australia
facility: Novo Nordisk Investigational Site
city: Clayton
country: Australia
facility: Novo Nordisk Investigational Site
city: Garran
country: Australia
facility: Novo Nordisk Investigational Site
city: Ringwood
country: Australia
facility: Novo Nordisk Investigational Site
city: Stones Corner
country: Australia
facility: Novo Nordisk Investigational Site
city: Woodville
country: Australia
facility: Novo Nordisk Investigational Site
city: Bornem
country: Belgium
facility: Novo Nordisk Investigational Site
city: Edegem
country: Belgium
facility: Novo Nordisk Investigational Site
city: Gent
country: Belgium
facility: Novo Nordisk Investigational Site
city: Leuven
country: Belgium
facility: Novo Nordisk Investigational Site
city: Luxembourg
country: Belgium
facility: Novo Nordisk Investigational Site
city: Fredericia
country: Denmark
facility: Novo Nordisk Investigational Site
city: Frederiksberg
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hvidovre
country: Denmark
facility: Novo Nordisk Investigational Site
city: København
country: Denmark
facility: Novo Nordisk Investigational Site
city: Middelfart
country: Denmark
facility: Novo Nordisk Investigational Site
city: Odense
country: Denmark
facility: Novo Nordisk Investigational Site
city: Vejle
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
city: Espoo
country: Finland
facility: Novo Nordisk Investigational Site
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Joensuu
country: Finland
facility: Novo Nordisk Investigational Site
city: Kemi
country: Finland
facility: Novo Nordisk Investigational Site
city: Vantaa
country: Finland
facility: Novo Nordisk Investigational Site
city: ANGERS cedex 09
country: France
facility: Novo Nordisk Investigational Site
city: Avignon
country: France
facility: Novo Nordisk Investigational Site
city: Bondy
country: France
facility: Novo Nordisk Investigational Site
city: Corbeil Essonnes
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: MONTPELLIER cedex 5
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: 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: Rennes
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: Amersfoort
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Apeldoorn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Brunssum
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Haag
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Eindhoven
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Haarlem
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Hengelo
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Utrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Bergen
country: Norway
facility: Novo Nordisk Investigational Site
city: Jessheim
country: Norway
facility: Novo Nordisk Investigational Site
city: Kongsvinger
country: Norway
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Sarpsborg
country: Norway
facility: Novo Nordisk Investigational Site
city: Stavanger
country: Norway
facility: Novo Nordisk Investigational Site
city: Stord
country: Norway
facility: Novo Nordisk Investigational Site
city: Trondheim
country: Norway
facility: Novo Nordisk Investigational Site
city: Falun
country: Sweden
facility: Novo Nordisk Investigational Site
city: Helsingborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Karlstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Lund
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: Umeå
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uppsala
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: Abergavenny
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Blackburn
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bolton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cosham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Derby
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Gillingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Guildford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Kettering
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Livingstone
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Llantrisant
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Newcastle
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Northampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Norwich
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nottingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Oxford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sidcup
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Stevenage
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Taunton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: York
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther. 2004 May;26(5):724-36. doi: 10.1016/s0149-2918(04)90072-0.