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

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.

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date February 1, 2001
Completion Date November 12, 2001
Primary Completion Date November 12, 2001
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
The change in the level of glycosylated haemoglobin(HbA1c) From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)
Enrollment 752
Condition
Intervention

Intervention Type: Drug

Intervention Name: Insulin detemir

Arm Group Label: Insulin detemir

Intervention Type: Drug

Intervention Name: NPH insulin

Arm Group Label: NPH insulin

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Novo Nordisk Investigational Site | Broadmeadow, New South Wales, 2292, Australia
Novo Nordisk Investigational Site | Ashford, 5035, Australia
Novo Nordisk Investigational Site | Box Hill, 3128, Australia
Novo Nordisk Investigational Site | Clayton, 3168, Australia
Novo Nordisk Investigational Site | Garran, 2605, Australia
Novo Nordisk Investigational Site | Ringwood, 3134, Australia
Novo Nordisk Investigational Site | Stones Corner, 4120, Australia
Novo Nordisk Investigational Site | Woodville, 5011, Australia
Novo Nordisk Investigational Site | Bornem, 2880, Belgium
Novo Nordisk Investigational Site | Edegem, 2650, Belgium
Novo Nordisk Investigational Site | Gent, 9000, Belgium
Novo Nordisk Investigational Site | Leuven, 3000, Belgium
Novo Nordisk Investigational Site | Luxembourg, 1210, Belgium
Novo Nordisk Investigational Site | Fredericia, 7000, Denmark
Novo Nordisk Investigational Site | Frederiksberg, 2000, Denmark
Novo Nordisk Investigational Site | Hvidovre, 2650, Denmark
Novo Nordisk Investigational Site | København, 2400, Denmark
Novo Nordisk Investigational Site | Middelfart, Denmark
Novo Nordisk Investigational Site | Odense, 5000, Denmark
Novo Nordisk Investigational Site | Vejle, 7100, Denmark
Novo Nordisk Investigational Site | Århus C, 8000, Denmark
Novo Nordisk Investigational Site | Espoo, 02740, Finland
Novo Nordisk Investigational Site | Helsinki, 00250, Finland
Novo Nordisk Investigational Site | Joensuu, 80210, Finland
Novo Nordisk Investigational Site | Kemi, 94100, Finland
Novo Nordisk Investigational Site | Vantaa, 01400, Finland
Novo Nordisk Investigational Site | ANGERS cedex 09, 49033, France
Novo Nordisk Investigational Site | Avignon, 84902, France
Novo Nordisk Investigational Site | Bondy, 93143, France
Novo Nordisk Investigational Site | Corbeil Essonnes, 91106, France
Novo Nordisk Investigational Site | LA ROCHELLE cedex, 17019, France
Novo Nordisk Investigational Site | Le Creusot, 71200, France
Novo Nordisk Investigational Site | MONTPELLIER cedex 5, 34295, France
Novo Nordisk Investigational Site | Narbonne, 11108, France
Novo Nordisk Investigational Site | NEVERS cedex, 58033, France
Novo Nordisk Investigational Site | Paris Cedex 10, 75475, France
Novo Nordisk Investigational Site | Paris, 75877, France
Novo Nordisk Investigational Site | Paris, 75908, France
Novo Nordisk Investigational Site | Poitiers, 86000, France
Novo Nordisk Investigational Site | Rennes, 35056, France
Novo Nordisk Investigational Site | Dublin, DUBLIN 8, Ireland
Novo Nordisk Investigational Site | Dublin, Ireland
Novo Nordisk Investigational Site | Amersfoort, 3816 CP, Netherlands
Novo Nordisk Investigational Site | Apeldoorn, 7334 DZ, Netherlands
Novo Nordisk Investigational Site | Brunssum, 6442 BE, Netherlands
Novo Nordisk Investigational Site | Den Haag, 2512 VA, Netherlands
Novo Nordisk Investigational Site | Eindhoven, 5631 BM, Netherlands
Novo Nordisk Investigational Site | Haarlem, 2012 CE, Netherlands
Novo Nordisk Investigational Site | Hengelo, 7555 DL, Netherlands
Novo Nordisk Investigational Site | Utrecht, 3582 KE, Netherlands
Novo Nordisk Investigational Site | Bergen, NO-5012, Norway
Novo Nordisk Investigational Site | Jessheim, 2050, Norway
Novo Nordisk Investigational Site | Kongsvinger, 2226, Norway
Novo Nordisk Investigational Site | Oslo, 0284, Norway
Novo Nordisk Investigational Site | Oslo, 0407, Norway
Novo Nordisk Investigational Site | Sarpsborg, 1702, Norway
Novo Nordisk Investigational Site | Stavanger, 4011, Norway
Novo Nordisk Investigational Site | Stord, 5400, Norway
Novo Nordisk Investigational Site | Trondheim, 7006, Norway
Novo Nordisk Investigational Site | Falun, 791 82, Sweden
Novo Nordisk Investigational Site | Helsingborg, 251 87, Sweden
Novo Nordisk Investigational Site | Karlstad, 651 85, Sweden
Novo Nordisk Investigational Site | Lund, 221 85, Sweden
Novo Nordisk Investigational Site | Skövde, 541 85, Sweden
Novo Nordisk Investigational Site | Stockholm, 141 86, Sweden
Novo Nordisk Investigational Site | Umeå, 901 85, Sweden
Novo Nordisk Investigational Site | Uppsala, 751 85, Sweden
Novo Nordisk Investigational Site | Värnamo, 331 85, Sweden
Novo Nordisk Investigational Site | Örebro, 701 85, Sweden
Novo Nordisk Investigational Site | Abergavenny, NP7 7EG, United Kingdom
Novo Nordisk Investigational Site | Blackburn, BB3 3LR, United Kingdom
Novo Nordisk Investigational Site | Bolton, BL1 4QS, United Kingdom
Novo Nordisk Investigational Site | Bristol, BS10 5NB, United Kingdom
Novo Nordisk Investigational Site | Cosham, PO6 3LY, United Kingdom
Novo Nordisk Investigational Site | Derby, DE7 1DY, United Kingdom
Novo Nordisk Investigational Site | Gillingham, ME7 5NY, United Kingdom
Novo Nordisk Investigational Site | Glasgow, G4 0SF, United Kingdom
Novo Nordisk Investigational Site | Glasgow, G42 9TY, United Kingdom
Novo Nordisk Investigational Site | Guildford, GU2 7XX, United Kingdom
Novo Nordisk Investigational Site | Kettering, NN16 8UZ, United Kingdom
Novo Nordisk Investigational Site | Livingstone, EH54 6PP, United Kingdom
Novo Nordisk Investigational Site | Llantrisant, CF72 8XR, United Kingdom
Novo Nordisk Investigational Site | London, SE1 7EH, United Kingdom
Novo Nordisk Investigational Site | Newcastle, NE7 7DN, United Kingdom
Novo Nordisk Investigational Site | Northampton, NN1 5BD, United Kingdom
Novo Nordisk Investigational Site | Norwich, NR1 3SR, United Kingdom
Novo Nordisk Investigational Site | Nottingham, NG5 1PB, United Kingdom
Novo Nordisk Investigational Site | Oxford, OX2 6HE, United Kingdom
Novo Nordisk Investigational Site | Sheffield, S5 7AU, United Kingdom
Novo Nordisk Investigational Site | Sidcup, DA14 6LT, United Kingdom
Novo Nordisk Investigational Site | Stevenage, SG1 4AB, United Kingdom
Novo Nordisk Investigational Site | Taunton, TA1 5DA, United Kingdom
Novo Nordisk Investigational Site | York, YO3 7HE, United Kingdom
Location Countries

Australia

Belgium

Denmark

Finland

France

Ireland

Netherlands

Norway

Sweden

United Kingdom

Verification Date

July 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Insulin detemir

Type: Experimental

Label: NPH insulin

Type: Active Comparator

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov