Diabetes Clinical Trial
Official title:
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.
| Status | Completed |
| Enrollment | 447 |
| Est. completion date | December 2005 |
| Est. primary completion date | December 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 1 diabetes for at least 12 months - Current treatment with basal-bolus insulin regimen for more than or equal to 3 months - HbA1c less than or equal to 11.0% Exclusion Criteria: - Proliferative retinopathy or maculopathy - Recurrent major hypoglycaemia - Impaired hepatic or renal function - Cardiac problems or uncontrolled hypertension |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Kuopio | |
| Finland | Novo Nordisk Investigational Site | Oulu | |
| Finland | Novo Nordisk Investigational Site | Pori | |
| Finland | Novo Nordisk Investigational Site | Vantaa | |
| France | Novo Nordisk Investigational Site | ANGERS cedex 09 | |
| France | Novo Nordisk Investigational Site | Antibes | |
| France | Novo Nordisk Investigational Site | Brest | |
| France | Novo Nordisk Investigational Site | GRENOBLE cedex | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Mougins | |
| France | Novo Nordisk Investigational Site | TOULOUSE cedex | |
| Germany | Novo Nordisk Investigational Site | Alsdorf | |
| Germany | Novo Nordisk Investigational Site | Bad Kreuznach | |
| Germany | Novo Nordisk Investigational Site | Dormagen | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Flensburg | |
| Germany | Novo Nordisk Investigational Site | Friedrichsthal | |
| Germany | Novo Nordisk Investigational Site | Genthin | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Herrenberg | |
| Germany | Novo Nordisk Investigational Site | Kippenheim | |
| Germany | Novo Nordisk Investigational Site | Rehlingen-Siersburg | |
| Germany | Novo Nordisk Investigational Site | Speyer | |
| Germany | Novo Nordisk Investigational Site | St. Ingbert | |
| Germany | Novo Nordisk Investigational Site | Völklingen | |
| Germany | Novo Nordisk Investigational Site | Würzburg | |
| Netherlands | Novo Nordisk Investigational Site | Almere | |
| Netherlands | Novo Nordisk Investigational Site | Apeldoorn | |
| Netherlands | Novo Nordisk Investigational Site | Capelle a/d IJssel | |
| Netherlands | Novo Nordisk Investigational Site | Dordrecht | |
| Netherlands | Novo Nordisk Investigational Site | Leeuwarden | |
| Netherlands | Novo Nordisk Investigational Site | Zoetermeer | |
| Sweden | Novo Nordisk Investigational Site | Norrköping | |
| Sweden | Novo Nordisk Investigational Site | Örebro | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Sweden | Novo Nordisk Investigational Site | Stockholm | |
| Sweden | Novo Nordisk Investigational Site | Umeå | |
| Sweden | Novo Nordisk Investigational Site | Växjö | |
| United Kingdom | Novo Nordisk Investigational Site | Abergavenny | |
| United Kingdom | Novo Nordisk Investigational Site | Ayr | |
| United Kingdom | Novo Nordisk Investigational Site | Brighton | |
| United Kingdom | Novo Nordisk Investigational Site | Bristol | |
| United Kingdom | Novo Nordisk Investigational Site | Cosham | |
| United Kingdom | Novo Nordisk Investigational Site | Dundee | |
| United Kingdom | Novo Nordisk Investigational Site | Glasgow | |
| United Kingdom | Novo Nordisk Investigational Site | Livingstone | |
| United Kingdom | Novo Nordisk Investigational Site | Plymouth | |
| United Kingdom | Novo Nordisk Investigational Site | Sheffield | |
| United Kingdom | Novo Nordisk Investigational Site | Watford | |
| United Kingdom | Novo Nordisk Investigational Site | Wirral, Merseyside | |
| United States | Novo Nordisk Investigational Site | Anaheim | California |
| United States | Novo Nordisk Investigational Site | Asheville | North Carolina |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Berlin | New Jersey |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Detroit | Michigan |
| United States | Novo Nordisk Investigational Site | Hollywood | Florida |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Huntington Beach | California |
| United States | Novo Nordisk Investigational Site | Hyattsville | Maryland |
| United States | Novo Nordisk Investigational Site | Idaho Falls | Idaho |
| United States | Novo Nordisk Investigational Site | Inglewood | California |
| United States | Novo Nordisk Investigational Site | Irvine | California |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | La Jolla | California |
| United States | Novo Nordisk Investigational Site | Lake Mary | Florida |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Melbourne | Florida |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | Sea Girt | New Jersey |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Vero Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Finland, France, Germany, Netherlands, Sweden, United Kingdom,
Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | after 1 year trial period | ||
| Secondary | Adverse events | |||
| Secondary | Body weight | |||
| Secondary | Hypoglycemia | |||
| Secondary | Blood glucose | |||
| Secondary | Insulin Treatment Satisfaction |
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