Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in 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 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 2 diabetes.
| Status | Completed |
| Enrollment | 324 |
| 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 2 diabetes for at least 12 months - Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs - BMI of maximum 40 kg/m2 - HbA1c greater than or equal to 7.0% and 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 | Espoo | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| Finland | Novo Nordisk Investigational Site | Kurikka | |
| Finland | Novo Nordisk Investigational Site | Lahti | |
| Finland | Novo Nordisk Investigational Site | Lapua | |
| Finland | Novo Nordisk Investigational Site | Oulu | |
| Finland | Novo Nordisk Investigational Site | Turku | |
| France | Novo Nordisk Investigational Site | Brest | |
| France | Novo Nordisk Investigational Site | Le Mans | |
| France | Novo Nordisk Investigational Site | MONTPELLIER cedex 5 | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | Narbonne | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | Orleans | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| Norway | Novo Nordisk Investigational Site | Bergen | |
| Norway | Novo Nordisk Investigational Site | Notodden | |
| Norway | Novo Nordisk Investigational Site | Sarpsborg | |
| Norway | Novo Nordisk Investigational Site | Ski | |
| Norway | Novo Nordisk Investigational Site | Stavanger | |
| Norway | Novo Nordisk Investigational Site | Trondheim | |
| Sweden | Novo Nordisk Investigational Site | Ängelholm | |
| Sweden | Novo Nordisk Investigational Site | Falun | |
| Sweden | Novo Nordisk Investigational Site | Göteborg | |
| Sweden | Novo Nordisk Investigational Site | Kalmar | |
| Sweden | Novo Nordisk Investigational Site | Lund | |
| Sweden | Novo Nordisk Investigational Site | Lund | |
| Sweden | Novo Nordisk Investigational Site | Malmö | |
| Sweden | Novo Nordisk Investigational Site | Motala | |
| Sweden | Novo Nordisk Investigational Site | Oskarshamn | |
| Sweden | Novo Nordisk Investigational Site | Uddevalla | |
| United States | Novo Nordisk Investigational Site | Asheville | North Carolina |
| United States | Novo Nordisk Investigational Site | Athens | Georgia |
| United States | Novo Nordisk Investigational Site | Berlin | New Jersey |
| United States | Novo Nordisk Investigational Site | Boca Raton | Florida |
| 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 | Hermitage | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Idaho Falls | Idaho |
| United States | Novo Nordisk Investigational Site | Inglewood | California |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Lake Mary | Florida |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Little Rock | Arkansas |
| United States | Novo Nordisk Investigational Site | Melbourne | Florida |
| United States | Novo Nordisk Investigational Site | Newport News | Virginia |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Orlando | Florida |
| United States | Novo Nordisk Investigational Site | Palm Harbor | Florida |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Richmond | Virginia |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Francisco | California |
| United States | Novo Nordisk Investigational Site | Santa Ana | California |
| United States | Novo Nordisk Investigational Site | Spring Valley | California |
| United States | Novo Nordisk Investigational Site | Tacoma | Washington |
| 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, Norway, Sweden,
Hollander P, Cooper J, Bregnhøj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients w — 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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