Diabetes Mellitus, Type 1 Clinical Trial
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.
| Verified date | July 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 752 |
| Est. completion date | November 12, 2001 |
| Est. primary completion date | November 12, 2001 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novo Nordisk Investigational Site | Ashford | |
| Australia | Novo Nordisk Investigational Site | Box Hill | |
| Australia | Novo Nordisk Investigational Site | Broadmeadow | New South Wales |
| Australia | Novo Nordisk Investigational Site | Clayton | |
| Australia | Novo Nordisk Investigational Site | Garran | |
| Australia | Novo Nordisk Investigational Site | Ringwood | |
| Australia | Novo Nordisk Investigational Site | Stones Corner | |
| Australia | Novo Nordisk Investigational Site | Woodville | |
| Belgium | Novo Nordisk Investigational Site | Bornem | |
| Belgium | Novo Nordisk Investigational Site | Edegem | |
| Belgium | Novo Nordisk Investigational Site | Gent | |
| Belgium | Novo Nordisk Investigational Site | Leuven | |
| Belgium | Novo Nordisk Investigational Site | Luxembourg | |
| Denmark | Novo Nordisk Investigational Site | Århus C | |
| Denmark | Novo Nordisk Investigational Site | Fredericia | |
| Denmark | Novo Nordisk Investigational Site | Frederiksberg | |
| Denmark | Novo Nordisk Investigational Site | Hvidovre | |
| Denmark | Novo Nordisk Investigational Site | København | |
| Denmark | Novo Nordisk Investigational Site | Middelfart | |
| Denmark | Novo Nordisk Investigational Site | Odense | |
| Denmark | Novo Nordisk Investigational Site | Vejle | |
| Finland | Novo Nordisk Investigational Site | Espoo | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Joensuu | |
| Finland | Novo Nordisk Investigational Site | Kemi | |
| Finland | Novo Nordisk Investigational Site | Vantaa | |
| France | Novo Nordisk Investigational Site | ANGERS cedex 09 | |
| France | Novo Nordisk Investigational Site | Avignon | |
| France | Novo Nordisk Investigational Site | Bondy | |
| France | Novo Nordisk Investigational Site | Corbeil Essonnes | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Le Creusot | |
| France | Novo Nordisk Investigational Site | MONTPELLIER cedex 5 | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Paris Cedex 10 | |
| France | Novo Nordisk Investigational Site | Poitiers | |
| France | Novo Nordisk Investigational Site | Rennes | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Netherlands | Novo Nordisk Investigational Site | Amersfoort | |
| Netherlands | Novo Nordisk Investigational Site | Apeldoorn | |
| Netherlands | Novo Nordisk Investigational Site | Brunssum | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Eindhoven | |
| Netherlands | Novo Nordisk Investigational Site | Haarlem | |
| Netherlands | Novo Nordisk Investigational Site | Hengelo | |
| Netherlands | Novo Nordisk Investigational Site | Utrecht | |
| Norway | Novo Nordisk Investigational Site | Bergen | |
| Norway | Novo Nordisk Investigational Site | Jessheim | |
| Norway | Novo Nordisk Investigational Site | Kongsvinger | |
| Norway | Novo Nordisk Investigational Site | Oslo | |
| Norway | Novo Nordisk Investigational Site | Oslo | |
| Norway | Novo Nordisk Investigational Site | Sarpsborg | |
| Norway | Novo Nordisk Investigational Site | Stavanger | |
| Norway | Novo Nordisk Investigational Site | Stord | |
| Norway | Novo Nordisk Investigational Site | Trondheim | |
| Sweden | Novo Nordisk Investigational Site | Falun | |
| Sweden | Novo Nordisk Investigational Site | Helsingborg | |
| Sweden | Novo Nordisk Investigational Site | Karlstad | |
| Sweden | Novo Nordisk Investigational Site | Lund | |
| Sweden | Novo Nordisk Investigational Site | Örebro | |
| Sweden | Novo Nordisk Investigational Site | Skövde | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Sweden | Novo Nordisk Investigational Site | Umeå | |
| Sweden | Novo Nordisk Investigational Site | Uppsala | |
| Sweden | Novo Nordisk Investigational Site | Värnamo | |
| United Kingdom | Novo Nordisk Investigational Site | Abergavenny | |
| United Kingdom | Novo Nordisk Investigational Site | Blackburn | |
| United Kingdom | Novo Nordisk Investigational Site | Bolton | |
| United Kingdom | Novo Nordisk Investigational Site | Bristol | |
| United Kingdom | Novo Nordisk Investigational Site | Cosham | |
| United Kingdom | Novo Nordisk Investigational Site | Derby | |
| United Kingdom | Novo Nordisk Investigational Site | Gillingham | |
| United Kingdom | Novo Nordisk Investigational Site | Glasgow | |
| United Kingdom | Novo Nordisk Investigational Site | Glasgow | |
| United Kingdom | Novo Nordisk Investigational Site | Guildford | |
| United Kingdom | Novo Nordisk Investigational Site | Kettering | |
| United Kingdom | Novo Nordisk Investigational Site | Livingstone | |
| United Kingdom | Novo Nordisk Investigational Site | Llantrisant | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | Newcastle | |
| United Kingdom | Novo Nordisk Investigational Site | Northampton | |
| United Kingdom | Novo Nordisk Investigational Site | Norwich | |
| United Kingdom | Novo Nordisk Investigational Site | Nottingham | |
| United Kingdom | Novo Nordisk Investigational Site | Oxford | |
| United Kingdom | Novo Nordisk Investigational Site | Sheffield | |
| United Kingdom | Novo Nordisk Investigational Site | Sidcup | |
| United Kingdom | Novo Nordisk Investigational Site | Stevenage | |
| United Kingdom | Novo Nordisk Investigational Site | Taunton | |
| United Kingdom | Novo Nordisk Investigational Site | York |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Australia, Belgium, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) |
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