Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 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 aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.
| Status | Completed |
| Enrollment | 583 |
| Est. completion date | November 2004 |
| Est. primary completion date | November 2004 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 Diabetes for more than 12 months, and no previous insulin treatment - Oral Antidiabetic Drug treatment for at least 4 months - Body Mass Index (BMI) less than 40 kg/m2 - HbA1c 7.5-10.0% Exclusion Criteria: - Current or previous treatment with thiazolidinediones within the last 6 months - Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months - Proliferative retinopathy or maculopathy - Known hypoglycaemia unawareness |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novo Nordisk Investigational Site | Ebreichsdorf | |
| Austria | Novo Nordisk Investigational Site | Gratwein | |
| Austria | Novo Nordisk Investigational Site | Graz | |
| Austria | Novo Nordisk Investigational Site | Neunkirchen | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wolfsberg | |
| Belgium | Novo Nordisk Investigational Site | Bonheiden | |
| Belgium | Novo Nordisk Investigational Site | Brussels | |
| Belgium | Novo Nordisk Investigational Site | Edegem | |
| Belgium | Novo Nordisk Investigational Site | Gent | |
| Belgium | Novo Nordisk Investigational Site | Leuven | |
| France | Novo Nordisk Investigational Site | Besancon | |
| France | Novo Nordisk Investigational Site | Bondy | |
| France | Novo Nordisk Investigational Site | Grenoble | |
| France | Novo Nordisk Investigational Site | LA ROCHELLE cedex | |
| France | Novo Nordisk Investigational Site | Lyon | |
| France | Novo Nordisk Investigational Site | Nantes | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | Nimes | |
| 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 | Strasbourg | |
| France | Novo Nordisk Investigational Site | TOULOUSE cedex | |
| Germany | Novo Nordisk Investigational Site | Bad Kreuznach | |
| Germany | Novo Nordisk Investigational Site | Bad Mergentheim | |
| Germany | Novo Nordisk Investigational Site | Bad Neuenahr-Ahrweiler | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Flensburg | |
| Germany | Novo Nordisk Investigational Site | Frankfurt | |
| Germany | Novo Nordisk Investigational Site | Freiburg | |
| Germany | Novo Nordisk Investigational Site | Friedrichsthal | |
| Germany | Novo Nordisk Investigational Site | Furth | |
| Germany | Novo Nordisk Investigational Site | Genthin | |
| Germany | Novo Nordisk Investigational Site | Giessen | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Heidelberg | |
| Germany | Novo Nordisk Investigational Site | Krefeld | |
| Germany | Novo Nordisk Investigational Site | Ludwigshafen | |
| Germany | Novo Nordisk Investigational Site | Marl | |
| Germany | Novo Nordisk Investigational Site | München | |
| Germany | Novo Nordisk Investigational Site | Neumünster | |
| Germany | Novo Nordisk Investigational Site | Neuss | |
| Germany | Novo Nordisk Investigational Site | Nürnberg | |
| Germany | Novo Nordisk Investigational Site | Rehlingen-Siersburg | |
| Germany | Novo Nordisk Investigational Site | Saarbrücken | |
| Germany | Novo Nordisk Investigational Site | Schaafheim | |
| Germany | Novo Nordisk Investigational Site | Schwabenheim | |
| Germany | Novo Nordisk Investigational Site | Schwedt | |
| Germany | Novo Nordisk Investigational Site | St. Ingbert | |
| Germany | Novo Nordisk Investigational Site | Völklingen | |
| Germany | Novo Nordisk Investigational Site | Würzburg | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| Ireland | Novo Nordisk Investigational Site | Dublin | |
| United Kingdom | Novo Nordisk Investigational Site | Ayr | |
| United Kingdom | Novo Nordisk Investigational Site | Barnsley | |
| United Kingdom | Novo Nordisk Investigational Site | Bolton | |
| United Kingdom | Novo Nordisk Investigational Site | Bradford | |
| United Kingdom | Novo Nordisk Investigational Site | Church Village | |
| 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 | Harrow | |
| United Kingdom | Novo Nordisk Investigational Site | Leicester | |
| United Kingdom | Novo Nordisk Investigational Site | Leicester | |
| United Kingdom | Novo Nordisk Investigational Site | Livingstone | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | Newcastle | |
| United Kingdom | Novo Nordisk Investigational Site | Poole | |
| United Kingdom | Novo Nordisk Investigational Site | Salford | |
| United Kingdom | Novo Nordisk Investigational Site | Swansea | |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Chesterfield | Missouri |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Greenbrae | California |
| United States | Novo Nordisk Investigational Site | Kettering | Ohio |
| United States | Novo Nordisk Investigational Site | La Mesa | California |
| United States | Novo Nordisk Investigational Site | Lincoln | Nebraska |
| United States | Novo Nordisk Investigational Site | Mt. Pleasant | South Carolina |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Pleasantville | New Jersey |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | Seattle | Washington |
| United States | Novo Nordisk Investigational Site | Springfield | Illinois |
| United States | Novo Nordisk Investigational Site | St. Louis | Missouri |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Warrenton | Virginia |
| United States | Novo Nordisk Investigational Site | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Austria, Belgium, France, Germany, Ireland, United Kingdom,
Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 dia — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | after 52 weeks | ||
| Secondary | Insulin antibodies | |||
| Secondary | Incident of hypoglycaemic episodes and adverse events | |||
| Secondary | Plasma glucose profiles | |||
| Secondary | Change in body weight |
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