Diabetes Mellitus, Type 2 Clinical Trial
— PreFEROfficial title:
Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus
| Verified date | June 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 efficacy and safety of an intensified treatment
regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more
convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in
subjects with type 2 diabetes.
| Status | Completed |
| Enrollment | 719 |
| Est. completion date | March 3, 2005 |
| Est. primary completion date | March 3, 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes - Duration of type 2 diabetes for at least 6 months since diagnosis - Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily - BMI below 40 kg/m2 - HbA1c between 7-12% - Able and willing to perform self-monitoring of capillary blood glucose Exclusion Criteria: - Current antidiabetic treatment with combination of three or more oral antidiabetic drugs - Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed) - Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator - Known or suspected allergy to trial product or related products - Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures - Receipt of any investigational drug within 4 weeks prior to this trial - Previous participation in this trial |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novo Nordisk Investigational Site | Graz | |
| Austria | Novo Nordisk Investigational Site | Linz | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Austria | Novo Nordisk Investigational Site | Wien | |
| Germany | Novo Nordisk Investigational Site | Alsdorf | |
| Germany | Novo Nordisk Investigational Site | Altenburg | |
| Germany | Novo Nordisk Investigational Site | Altenkirchen | |
| Germany | Novo Nordisk Investigational Site | Altenstadt | |
| Germany | Novo Nordisk Investigational Site | Aschaffenburg | |
| Germany | Novo Nordisk Investigational Site | Augsburg | |
| Germany | Novo Nordisk Investigational Site | Bad Harzburg | |
| Germany | Novo Nordisk Investigational Site | Bad Heilbrunn | |
| Germany | Novo Nordisk Investigational Site | Bad Kreuznach | |
| Germany | Novo Nordisk Investigational Site | Bad Lauterberg | |
| Germany | Novo Nordisk Investigational Site | Bad Lippspringe | |
| Germany | Novo Nordisk Investigational Site | Bad Mergentheim | |
| Germany | Novo Nordisk Investigational Site | Bad Neuenahr-Ahrweiler | |
| Germany | Novo Nordisk Investigational Site | Bad Oldesloe | |
| Germany | Novo Nordisk Investigational Site | Bad Staffelstein | |
| Germany | Novo Nordisk Investigational Site | Bensheim | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Bochum | |
| Germany | Novo Nordisk Investigational Site | Damme | |
| Germany | Novo Nordisk Investigational Site | Diez | |
| Germany | Novo Nordisk Investigational Site | Dinslaken | |
| Germany | Novo Nordisk Investigational Site | Dormagen | |
| Germany | Novo Nordisk Investigational Site | Dortmund | |
| Germany | Novo Nordisk Investigational Site | Dortmund | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Dresden | |
| Germany | Novo Nordisk Investigational Site | Duisburg | |
| Germany | Novo Nordisk Investigational Site | Duisburg | |
| Germany | Novo Nordisk Investigational Site | Emmerich | |
| Germany | Novo Nordisk Investigational Site | Essen | |
| Germany | Novo Nordisk Investigational Site | Essen | |
| Germany | Novo Nordisk Investigational Site | Flensburg | |
| Germany | Novo Nordisk Investigational Site | Flörsheim | |
| Germany | Novo Nordisk Investigational Site | Forchheim | |
| Germany | Novo Nordisk Investigational Site | Frankfurt | |
| Germany | Novo Nordisk Investigational Site | Frankfurt | |
| Germany | Novo Nordisk Investigational Site | Frankfurt | |
| Germany | Novo Nordisk Investigational Site | Frankfurt | |
| Germany | Novo Nordisk Investigational Site | Freiburg | |
| Germany | Novo Nordisk Investigational Site | Freital | |
| Germany | Novo Nordisk Investigational Site | Gebhardshain | |
| Germany | Novo Nordisk Investigational Site | Genthin | |
| Germany | Novo Nordisk Investigational Site | Georgsmarienhütte | |
| Germany | Novo Nordisk Investigational Site | Giessen | |
| Germany | Novo Nordisk Investigational Site | Gotha | |
| Germany | Novo Nordisk Investigational Site | Halle | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hamburg | |
| Germany | Novo Nordisk Investigational Site | Hameln | |
| Germany | Novo Nordisk Investigational Site | Hannover | |
| Germany | Novo Nordisk Investigational Site | Herne | |
| Germany | Novo Nordisk Investigational Site | Herrenberg | |
| Germany | Novo Nordisk Investigational Site | Hildesheim | |
| Germany | Novo Nordisk Investigational Site | Hohenmölsen | |
| Germany | Novo Nordisk Investigational Site | Hünxe | |
| Germany | Novo Nordisk Investigational Site | Idar-Oberstein | |
| Germany | Novo Nordisk Investigational Site | Jena | |
| Germany | Novo Nordisk Investigational Site | Kaiserslautern | |
| Germany | Novo Nordisk Investigational Site | Karlsruhe | |
| Germany | Novo Nordisk Investigational Site | Krummennaab | |
| Germany | Novo Nordisk Investigational Site | Künzing | |
| Germany | Novo Nordisk Investigational Site | Landau | |
| Germany | Novo Nordisk Investigational Site | Langen | |
| Germany | Novo Nordisk Investigational Site | Lindenfels | |
| Germany | Novo Nordisk Investigational Site | Lübeck | |
| Germany | Novo Nordisk Investigational Site | Mainz | |
| Germany | Novo Nordisk Investigational Site | Marburg | |
| Germany | Novo Nordisk Investigational Site | Marktheidenfeld | |
| Germany | Novo Nordisk Investigational Site | Meppen | |
| Germany | Novo Nordisk Investigational Site | Mühlheim | |
| Germany | Novo Nordisk Investigational Site | München | |
| Germany | Novo Nordisk Investigational Site | Neumünster | |
| Germany | Novo Nordisk Investigational Site | Neuwied | |
| Germany | Novo Nordisk Investigational Site | Nittenau | |
| Germany | Novo Nordisk Investigational Site | Northeim | |
| Germany | Novo Nordisk Investigational Site | Oberhausen | |
| Germany | Novo Nordisk Investigational Site | Oberndorf | |
| Germany | Novo Nordisk Investigational Site | Oberursel | |
| Germany | Novo Nordisk Investigational Site | Offenbach | |
| Germany | Novo Nordisk Investigational Site | Osnabrück | |
| Germany | Novo Nordisk Investigational Site | Pforzheim | |
| Germany | Novo Nordisk Investigational Site | Pirna | |
| Germany | Novo Nordisk Investigational Site | Regensburg | |
| Germany | Novo Nordisk Investigational Site | Rehlingen-Siersburg | |
| Germany | Novo Nordisk Investigational Site | Saaldorf-Surheim | |
| Germany | Novo Nordisk Investigational Site | Saarbrücken | |
| Germany | Novo Nordisk Investigational Site | Sangerhausen | |
| Germany | Novo Nordisk Investigational Site | Schaafheim | |
| Germany | Novo Nordisk Investigational Site | Schkeuditz | |
| Germany | Novo Nordisk Investigational Site | Schlüchtern | |
| Germany | Novo Nordisk Investigational Site | Schwerin | |
| Germany | Novo Nordisk Investigational Site | Schwerin | |
| Germany | Novo Nordisk Investigational Site | Schwerte | |
| Germany | Novo Nordisk Investigational Site | Siegen | |
| Germany | Novo Nordisk Investigational Site | Simmern | |
| Germany | Novo Nordisk Investigational Site | Sinsheim | |
| Germany | Novo Nordisk Investigational Site | Sögel | |
| Germany | Novo Nordisk Investigational Site | Speyer | |
| Germany | Novo Nordisk Investigational Site | St. Ingbert | |
| Germany | Novo Nordisk Investigational Site | Stuttgart | |
| Germany | Novo Nordisk Investigational Site | Sulzbach-Rosenberg | |
| Germany | Novo Nordisk Investigational Site | Trier | |
| Germany | Novo Nordisk Investigational Site | Tübingen | |
| Germany | Novo Nordisk Investigational Site | Völklingen | |
| Germany | Novo Nordisk Investigational Site | Wallerfing | |
| Germany | Novo Nordisk Investigational Site | Wangen | |
| Germany | Novo Nordisk Investigational Site | Warburg | |
| Germany | Novo Nordisk Investigational Site | Wiesbaden | |
| Germany | Novo Nordisk Investigational Site | Wilhelmshaven | |
| Germany | Novo Nordisk Investigational Site | Würzburg | |
| Switzerland | Novo Nordisk Investigational Site | Basel-Bruderholz | |
| Switzerland | Novo Nordisk Investigational Site | Genève 14 | |
| Switzerland | Novo Nordisk Investigational Site | Lugano | |
| Switzerland | Novo Nordisk Investigational Site | St. Gallen | |
| Switzerland | Novo Nordisk Investigational Site | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Austria, Germany, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1c | after 6 months of treatment | ||
| Secondary | Incidence of hypoglycaemic episodes | |||
| Secondary | Adverse events | |||
| Secondary | Difference of HbA1c change between the two groups | after 13 weeks of treatment | ||
| Secondary | Fasting plasma glucose of treatment | after 13 and 26 weeks | ||
| Secondary | Change in weight |
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