Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

NCT ID: NCT03220425

Last Updated: 2017-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-01

Study Completion Date

2001-11-12

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Insulin detemir

Group Type EXPERIMENTAL

Insulin detemir

Intervention Type DRUG

NPH insulin

Group Type ACTIVE_COMPARATOR

NPH insulin

Intervention Type DRUG

Interventions

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Insulin detemir

Intervention Type DRUG

NPH insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Broadmeadow, New South Wales, Australia

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Ashford, , Australia

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Box Hill, , Australia

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Clayton, , Australia

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Garran, , Australia

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Ringwood, , Australia

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Stones Corner, , Australia

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Woodville, , Australia

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Bornem, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Luxembourg, , Belgium

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Århus C, , Denmark

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Copenhagen, , Denmark

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Fredericia, , Denmark

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Frederiksberg, , Denmark

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Hvidovre, , Denmark

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Middelfart, , Denmark

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Odense, , Denmark

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Vejle, , Denmark

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Espoo, , Finland

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Helsinki, , Finland

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Joensuu, , Finland

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Kemi, , Finland

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Vantaa, , Finland

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Angers, , France

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Avignon, , France

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Bondy, , France

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Corbeil-Essonnes, , France

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La Rochelle, , France

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Le Creusot, , France

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Montpellier, , France

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Narbonne, , France

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Nevers, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Poitiers, , France

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Rennes, , France

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Dublin, , Ireland

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Dublin, , Ireland

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Amersfoort, , Netherlands

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Apeldoorn, , Netherlands

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Brunssum, , Netherlands

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Eindhoven, , Netherlands

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Haarlem, , Netherlands

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Hengelo, , Netherlands

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The Hague, , Netherlands

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Utrecht, , Netherlands

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Bergen, , Norway

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Jessheim, , Norway

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Kongsvinger, , Norway

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Oslo, , Norway

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Oslo, , Norway

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Sarpsborg, , Norway

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Stavanger, , Norway

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Stord, , Norway

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Trondheim, , Norway

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Falun, , Sweden

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Helsingborg, , Sweden

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Karlstad, , Sweden

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Lund, , Sweden

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Örebro, , Sweden

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Skövde, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Värnamo, , Sweden

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Abergavenny, , United Kingdom

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Blackburn, , United Kingdom

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Bolton, , United Kingdom

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Bristol, , United Kingdom

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Cosham, , United Kingdom

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Derby, , United Kingdom

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Gillingham, , United Kingdom

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Glasgow, , United Kingdom

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Glasgow, , United Kingdom

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Guildford, , United Kingdom

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Kettering, , United Kingdom

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Livingstone, , United Kingdom

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Llantrisant, , United Kingdom

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London, , United Kingdom

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Newcastle, , United Kingdom

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Northampton, , United Kingdom

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Norwich, , United Kingdom

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Nottingham, , United Kingdom

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Oxford, , United Kingdom

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Sheffield, , United Kingdom

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Sidcup, , United Kingdom

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Stevenage, , United Kingdom

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Taunton, , United Kingdom

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York, , United Kingdom

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Countries

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Australia Belgium Denmark Finland France Ireland Netherlands Norway Sweden United Kingdom

References

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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.

Reference Type RESULT
PMID: 15220016 (View on PubMed)

Other Identifiers

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NN304-1335

Identifier Type: -

Identifier Source: org_study_id

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