Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus
| 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.
The aim of this trial is to investigate the safety and efficacy of insulin detemir combined
with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic
drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose
control.
| Status | Completed |
| Enrollment | 477 |
| Est. completion date | January 2004 |
| Est. primary completion date | January 2004 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes for at least 12 months since diagnosis - Insulin naive subjects - OAD treatment for at least 4 months alone or combined with no more than two OADs - Body mass index (BMI) below 35.0 kg/m2 - HbA1c between 7.5-10.0% - Able and willing to use twice a day injections for the entire trial period Exclusion Criteria: - Current or previous treatment with thiazolidiones within the last 6 months - OAD treatment with three or more OADs within the last 6 months - Acute insulin treatment for longer than 7 days in a row within the last 6 months - Secondary diabetes - Known maturity onset of diabetes of young (MODY) - Known or suspected allergy to trial product or related products |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Novo Nordisk Investigational Site | Arlon | |
| Belgium | Novo Nordisk Investigational Site | Gilly | |
| Belgium | Novo Nordisk Investigational Site | Huy | |
| Belgium | Novo Nordisk Investigational Site | Jumet | |
| Croatia | Novo Nordisk Investigational Site | Rijeka | |
| Croatia | Novo Nordisk Investigational Site | Zagreb | |
| Denmark | Novo Nordisk Investigational Site | Århus C | |
| Denmark | Novo Nordisk Investigational Site | Hjørring | |
| Denmark | Novo Nordisk Investigational Site | Hvidovre | |
| Denmark | Novo Nordisk Investigational Site | Kalundborg | |
| Denmark | Novo Nordisk Investigational Site | København | |
| Denmark | Novo Nordisk Investigational Site | København S | |
| Denmark | Novo Nordisk Investigational Site | Køge | |
| Denmark | Novo Nordisk Investigational Site | Slagelse | |
| France | Novo Nordisk Investigational Site | Amiens | |
| France | Novo Nordisk Investigational Site | Auxerre | |
| France | Novo Nordisk Investigational Site | Avignon | |
| France | Novo Nordisk Investigational Site | DAX | |
| France | Novo Nordisk Investigational Site | Evry | |
| France | Novo Nordisk Investigational Site | Mougins | |
| France | Novo Nordisk Investigational Site | Nanterre | |
| France | Novo Nordisk Investigational Site | NEVERS cedex | |
| France | Novo Nordisk Investigational Site | Rueil-Malmaison | |
| France | Novo Nordisk Investigational Site | Valenciennes | |
| France | Novo Nordisk Investigational Site | Venissieux | |
| Macedonia, The Former Yugoslav Republic of | Novo Nordisk Investigational Site | Skopje | |
| Norway | Novo Nordisk Investigational Site | Bekkestua | |
| Norway | Novo Nordisk Investigational Site | Bergen | |
| Norway | Novo Nordisk Investigational Site | Elverum | |
| Norway | Novo Nordisk Investigational Site | Gjettum | |
| Norway | Novo Nordisk Investigational Site | Gjøvik | |
| Norway | Novo Nordisk Investigational Site | Jessheim | |
| Norway | Novo Nordisk Investigational Site | Oslo | |
| Norway | Novo Nordisk Investigational Site | Rådal | |
| Norway | Novo Nordisk Investigational Site | Stavanger | |
| Poland | Novo Nordisk Investigational Site | Gniewkowo | |
| Poland | Novo Nordisk Investigational Site | Krakow | |
| Poland | Novo Nordisk Investigational Site | Lodz | |
| Poland | Novo Nordisk Investigational Site | Lublin | |
| Poland | Novo Nordisk Investigational Site | Rawa Mazowiecka | |
| Poland | Novo Nordisk Investigational Site | Szczecin | |
| Poland | Novo Nordisk Investigational Site | Tychy | |
| Poland | Novo Nordisk Investigational Site | Warsaw | |
| Poland | Novo Nordisk Investigational Site | Warsaw | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| Poland | Novo Nordisk Investigational Site | Wolomin | |
| Poland | Novo Nordisk Investigational Site | Zabrze | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Slovakia | Novo Nordisk Investigational Site | Trencin | |
| Sweden | Novo Nordisk Investigational Site | Falun | |
| Sweden | Novo Nordisk Investigational Site | Grästorp | |
| Sweden | Novo Nordisk Investigational Site | Kristianstad | |
| Sweden | Novo Nordisk Investigational Site | Linköping | |
| Sweden | Novo Nordisk Investigational Site | Lund | |
| Sweden | Novo Nordisk Investigational Site | Lund | |
| Sweden | Novo Nordisk Investigational Site | Trelleborg | |
| Sweden | Novo Nordisk Investigational Site | Umeå |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Belgium, Croatia, Denmark, France, Macedonia, The Former Yugoslav Republic of, Norway, Poland, Russian Federation, Slovakia, Sweden,
Davies MJ, Derezinski T, Pedersen CB, Clauson P. Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia. Diabetes Technol Ther. 2008 Aug;10(4):273-7. doi: 10.1089/dia.2008.0282. — View Citation
Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | after 26 weeks of treatment | ||
| Secondary | Fasting plasma glucose | |||
| Secondary | Within-subject variation | |||
| Secondary | Incidence of total hypoglycaemic episodes | |||
| Secondary | Body weight | |||
| Secondary | Incidence of adverse events | |||
| Secondary | Insulin antibodies |
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