Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients 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 this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.
| Status | Completed |
| Enrollment | 503 |
| Est. completion date | February 2006 |
| Est. primary completion date | February 2006 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes for at least 12 months - Currently treated with Oral Antidiabetic Drugs - BMI lesser than or equal to 40 kg/m2 - HbA1c greater than or equal 7.5 and lesser than or equal to 11% Exclusion Criteria: - Proliferative retinopathy or maculopathy - Recurrent major hypoglycaemia - uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Novo Nordisk Investigational Site | Aalborg | |
| Denmark | Novo Nordisk Investigational Site | Esbjerg | |
| Denmark | Novo Nordisk Investigational Site | Glostrup | |
| Denmark | Novo Nordisk Investigational Site | Herlev | |
| Denmark | Novo Nordisk Investigational Site | Hillerød | |
| Denmark | Novo Nordisk Investigational Site | Hjørring | |
| Denmark | Novo Nordisk Investigational Site | Horsens | |
| Denmark | Novo Nordisk Investigational Site | Hvidovre | |
| Denmark | Novo Nordisk Investigational Site | København | |
| Denmark | Novo Nordisk Investigational Site | København S | |
| Denmark | Novo Nordisk Investigational Site | Næstved | |
| Denmark | Novo Nordisk Investigational Site | Roskilde | |
| France | Novo Nordisk Investigational Site | Bagnols-sur-ceze | |
| France | Novo Nordisk Investigational Site | Besancon | |
| France | Novo Nordisk Investigational Site | Carcassonne | |
| France | Novo Nordisk Investigational Site | Corbeil Essonnes | |
| France | Novo Nordisk Investigational Site | DAX | |
| France | Novo Nordisk Investigational Site | MONTPELLIER cedex 5 | |
| France | Novo Nordisk Investigational Site | Quimper | |
| France | Novo Nordisk Investigational Site | Rueil-malmaison | |
| France | Novo Nordisk Investigational Site | Tours | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| Italy | Novo Nordisk Investigational Site | Cagliari | |
| Italy | Novo Nordisk Investigational Site | Catania | |
| Italy | Novo Nordisk Investigational Site | Genova | |
| Italy | Novo Nordisk Investigational Site | Messina | |
| Italy | Novo Nordisk Investigational Site | Monza | |
| Italy | Novo Nordisk Investigational Site | Napoli | |
| Italy | Novo Nordisk Investigational Site | Parma | |
| Italy | Novo Nordisk Investigational Site | Pescara | |
| Italy | Novo Nordisk Investigational Site | Prato | |
| Italy | Novo Nordisk Investigational Site | Roma | |
| Italy | Novo Nordisk Investigational Site | Torino | |
| Italy | Novo Nordisk Investigational Site | Treviso | |
| Netherlands | Novo Nordisk Investigational Site | Almelo | |
| Netherlands | Novo Nordisk Investigational Site | Den Bosch | |
| Netherlands | Novo Nordisk Investigational Site | Den Haag | |
| Netherlands | Novo Nordisk Investigational Site | Etten-Leur | |
| Netherlands | Novo Nordisk Investigational Site | Roelofarendsveen | |
| Netherlands | Novo Nordisk Investigational Site | Rotterdam | |
| Netherlands | Novo Nordisk Investigational Site | Vlodrop | |
| Norway | Novo Nordisk Investigational Site | Bergen | |
| Norway | Novo Nordisk Investigational Site | Bergen | |
| Norway | Novo Nordisk Investigational Site | Elverum | |
| Norway | Novo Nordisk Investigational Site | Gjøvik | |
| Norway | Novo Nordisk Investigational Site | Kongsvinger | |
| Norway | Novo Nordisk Investigational Site | Oslo | |
| Norway | Novo Nordisk Investigational Site | Oslo | |
| Norway | Novo Nordisk Investigational Site | Stavanger | |
| Norway | Novo Nordisk Investigational Site | Trondheim | |
| Spain | Novo Nordisk Investigational Site | Alcorcón | |
| Spain | Novo Nordisk Investigational Site | Almería | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Bilbao | |
| Spain | Novo Nordisk Investigational Site | Cádiz | |
| Spain | Novo Nordisk Investigational Site | Getafe | |
| Spain | Novo Nordisk Investigational Site | Gijón | |
| Spain | Novo Nordisk Investigational Site | Granada | |
| Spain | Novo Nordisk Investigational Site | Palma de Mallorca | |
| Spain | Novo Nordisk Investigational Site | Pamplona | |
| Spain | Novo Nordisk Investigational Site | Santa Cruz de Tenerife | |
| Spain | Novo Nordisk Investigational Site | Santiago de Compostela | |
| Spain | Novo Nordisk Investigational Site | Valencia | |
| Spain | Novo Nordisk Investigational Site | Valladolid | |
| Spain | Novo Nordisk Investigational Site | Valladolid | |
| United States | Novo Nordisk Investigational Site | Anaheim | California |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Cincinnati | Ohio |
| United States | Novo Nordisk Investigational Site | Concord | California |
| United States | Novo Nordisk Investigational Site | Connellsville | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Conroe | Texas |
| United States | Novo Nordisk Investigational Site | Dayton | Ohio |
| United States | Novo Nordisk Investigational Site | Denver | Colorado |
| United States | Novo Nordisk Investigational Site | Fall River | Massachusetts |
| United States | Novo Nordisk Investigational Site | Fullerton | California |
| United States | Novo Nordisk Investigational Site | Grand Forks | North Dakota |
| United States | Novo Nordisk Investigational Site | Greer | South Carolina |
| United States | Novo Nordisk Investigational Site | Jefferson City | Missouri |
| United States | Novo Nordisk Investigational Site | Killeen | Texas |
| United States | Novo Nordisk Investigational Site | La Jolla | California |
| United States | Novo Nordisk Investigational Site | Lake Mary | Florida |
| United States | Novo Nordisk Investigational Site | Lancaster | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lewiston | New York |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | Mesa | Arizona |
| United States | Novo Nordisk Investigational Site | Norristown | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Orange | California |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Poway | California |
| United States | Novo Nordisk Investigational Site | Seattle | Washington |
| United States | Novo Nordisk Investigational Site | Springfield | Illinois |
| United States | Novo Nordisk Investigational Site | Waltham | Massachusetts |
| United States | Novo Nordisk Investigational Site | Williamsville | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Denmark, France, Italy, Netherlands, Norway, Spain,
Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006 Oct;28(10):156 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1C | after 20 weeks | ||
| Secondary | Adverse events | |||
| Secondary | body weight | |||
| Secondary | Hypoglycemia | |||
| Secondary | Blood glucose |
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