Diabetes Clinical Trial
Official title:
Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.
| Status | Completed |
| Enrollment | 347 |
| Est. completion date | August 2003 |
| Est. primary completion date | August 2003 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Type 1 diabetes for at least 12 months - Informed consent obtained - BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m2. - HbA1c equal to or less than 12.0% Exclusion Criteria: - Proliferate retinopathy or maculopathy - Total daily insulin dose greater than 2.00 IU/kg - Any condition or disease that rule out trial participation according to the judgement of the investigator. - Mental incapacity, unwillingness or language barriers precluding understanding or cooperation. - A life-style incompatible with trial participation |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Novo Nordisk Investigational Site | Bree | |
| Belgium | Novo Nordisk Investigational Site | Edegem | |
| Croatia | Novo Nordisk Investigational Site | Rijeka | |
| Denmark | Novo Nordisk Investigational Site | Glostrup | |
| Denmark | Novo Nordisk Investigational Site | Kolding | |
| Denmark | Novo Nordisk Investigational Site | Odense | |
| Denmark | Novo Nordisk Investigational Site | Viborg | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Oulu | |
| France | Novo Nordisk Investigational Site | Caen | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Rennes | |
| France | Novo Nordisk Investigational Site | TOULOUSE cedex | |
| Germany | Novo Nordisk Investigational Site | Frankfurt | |
| Germany | Novo Nordisk Investigational Site | Hannover | |
| Germany | Novo Nordisk Investigational Site | Kiel | |
| Germany | Novo Nordisk Investigational Site | Stuttgart | |
| Ireland | Novo Nordisk Investigational Site | Dublin 24 | |
| Israel | Novo Nordisk Investigational Site | Petah Tikva | |
| Macedonia, The Former Yugoslav Republic of | Novo Nordisk Investigational Site | Skopje | |
| Netherlands | Novo Nordisk Investigational Site | Eindhoven | |
| Netherlands | Novo Nordisk Investigational Site | Spijkenisse | |
| Netherlands | Novo Nordisk Investigational Site | Utrecht | |
| Norway | Novo Nordisk Investigational Site | Bodø | |
| Norway | Novo Nordisk Investigational Site | Gjøvik | |
| Norway | Novo Nordisk Investigational Site | Sarpsborg | |
| Norway | Novo Nordisk Investigational Site | Tønsberg | |
| Slovenia | Novo Nordisk Investigational Site | Ljubljana | |
| Spain | Novo Nordisk Investigational Site | Leganés | |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Sweden | Novo Nordisk Investigational Site | Helsingborg | |
| Sweden | Novo Nordisk Investigational Site | Linköping | |
| Sweden | Novo Nordisk Investigational Site | Lund | |
| Sweden | Novo Nordisk Investigational Site | Malmö | |
| Sweden | Novo Nordisk Investigational Site | Örebro | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Switzerland | Novo Nordisk Investigational Site | Zürich | |
| United Kingdom | Novo Nordisk Investigational Site | Aberdeen | |
| United Kingdom | Novo Nordisk Investigational Site | Belfast | |
| United Kingdom | Novo Nordisk Investigational Site | Birmingham | |
| United Kingdom | Novo Nordisk Investigational Site | Glasgow | |
| United Kingdom | Novo Nordisk Investigational Site | Stirling |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Belgium, Croatia, Denmark, Finland, France, Germany, Ireland, Israel, Macedonia, The Former Yugoslav Republic of, Netherlands, Norway, Slovenia, Spain, Sweden, Switzerland, United Kingdom,
Robertson KJ, Schoenle E, Gucev Z, Mordhorst L, Gall MA, Ludvigsson J. Insulin detemir compared with NPH insulin in children and adolescents with Type 1 diabetes. Diabet Med. 2007 Jan;24(1):27-34. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | after 26 weeks | ||
| Secondary | Adverse events | |||
| Secondary | body weight | |||
| Secondary | Antibodies | |||
| Secondary | Blood glucose | |||
| Secondary | Hypoglycaemia |
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