Clinical trial NCT00605020: Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes
Official title: Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: after 6 months of treatment
Secondary outcomes:
measure: Incidence of hypoglycaemic episodes
measure: Adverse events
measure: Difference of HbA1c change between the two groups
timeFrame: after 13 weeks of treatment
measure: Fasting plasma glucose of treatment
timeFrame: after 13 and 26 weeks
measure: Change in weight
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Linz
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Alsdorf
country: Germany
facility: Novo Nordisk Investigational Site
city: Altenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Altenkirchen
country: Germany
facility: Novo Nordisk Investigational Site
city: Altenstadt
country: Germany
facility: Novo Nordisk Investigational Site
city: Aschaffenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Augsburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Harzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Heilbrunn
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Kreuznach
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Lauterberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Lippspringe
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Mergentheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Neuenahr-Ahrweiler
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Oldesloe
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Staffelstein
country: Germany
facility: Novo Nordisk Investigational Site
city: Bensheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Bochum
country: Germany
facility: Novo Nordisk Investigational Site
city: Damme
country: Germany
facility: Novo Nordisk Investigational Site
city: Diez
country: Germany
facility: Novo Nordisk Investigational Site
city: Dinslaken
country: Germany
facility: Novo Nordisk Investigational Site
city: Dormagen
country: Germany
facility: Novo Nordisk Investigational Site
city: Dortmund
country: Germany
facility: Novo Nordisk Investigational Site
city: Dortmund
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Emmerich
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Essen
country: Germany
facility: Novo Nordisk Investigational Site
city: Flensburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Flörsheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Forchheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Freiburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Freital
country: Germany
facility: Novo Nordisk Investigational Site
city: Gebhardshain
country: Germany
facility: Novo Nordisk Investigational Site
city: Genthin
country: Germany
facility: Novo Nordisk Investigational Site
city: Georgsmarienhütte
country: Germany
facility: Novo Nordisk Investigational Site
city: Giessen
country: Germany
facility: Novo Nordisk Investigational Site
city: Gotha
country: Germany
facility: Novo Nordisk Investigational Site
city: Halle
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hameln
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Herne
country: Germany
facility: Novo Nordisk Investigational Site
city: Herrenberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hildesheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Hohenmölsen
country: Germany
facility: Novo Nordisk Investigational Site
city: Hünxe
country: Germany
facility: Novo Nordisk Investigational Site
city: Idar-Oberstein
country: Germany
facility: Novo Nordisk Investigational Site
city: Jena
country: Germany
facility: Novo Nordisk Investigational Site
city: Kaiserslautern
country: Germany
facility: Novo Nordisk Investigational Site
city: Karlsruhe
country: Germany
facility: Novo Nordisk Investigational Site
city: Krummennaab
country: Germany
facility: Novo Nordisk Investigational Site
city: Künzing
country: Germany
facility: Novo Nordisk Investigational Site
city: Landau
country: Germany
facility: Novo Nordisk Investigational Site
city: Langen
country: Germany
facility: Novo Nordisk Investigational Site
city: Lindenfels
country: Germany
facility: Novo Nordisk Investigational Site
city: Lübeck
country: Germany
facility: Novo Nordisk Investigational Site
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Marburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Marktheidenfeld
country: Germany
facility: Novo Nordisk Investigational Site
city: Meppen
country: Germany
facility: Novo Nordisk Investigational Site
city: Mühlheim
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Neumünster
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuwied
country: Germany
facility: Novo Nordisk Investigational Site
city: Nittenau
country: Germany
facility: Novo Nordisk Investigational Site
city: Northeim
country: Germany
facility: Novo Nordisk Investigational Site
city: Oberhausen
country: Germany
facility: Novo Nordisk Investigational Site
city: Oberndorf
country: Germany
facility: Novo Nordisk Investigational Site
city: Oberursel
country: Germany
facility: Novo Nordisk Investigational Site
city: Offenbach
country: Germany
facility: Novo Nordisk Investigational Site
city: Osnabrück
country: Germany
facility: Novo Nordisk Investigational Site
city: Pforzheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Pirna
country: Germany
facility: Novo Nordisk Investigational Site
city: Regensburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Saaldorf-Surheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Saarbrücken
country: Germany
facility: Novo Nordisk Investigational Site
city: Sangerhausen
country: Germany
facility: Novo Nordisk Investigational Site
city: Schaafheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Schkeuditz
country: Germany
facility: Novo Nordisk Investigational Site
city: Schlüchtern
country: Germany
facility: Novo Nordisk Investigational Site
city: Schwerin
country: Germany
facility: Novo Nordisk Investigational Site
city: Schwerin
country: Germany
facility: Novo Nordisk Investigational Site
city: Schwerte
country: Germany
facility: Novo Nordisk Investigational Site
city: Siegen
country: Germany
facility: Novo Nordisk Investigational Site
city: Simmern
country: Germany
facility: Novo Nordisk Investigational Site
city: Sinsheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Speyer
country: Germany
facility: Novo Nordisk Investigational Site
city: St. Ingbert
country: Germany
facility: Novo Nordisk Investigational Site
city: Stuttgart
country: Germany
facility: Novo Nordisk Investigational Site
city: Sulzbach-Rosenberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Sögel
country: Germany
facility: Novo Nordisk Investigational Site
city: Trier
country: Germany
facility: Novo Nordisk Investigational Site
city: Tübingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Völklingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Wallerfing
country: Germany
facility: Novo Nordisk Investigational Site
city: Wangen
country: Germany
facility: Novo Nordisk Investigational Site
city: Warburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Wiesbaden
country: Germany
facility: Novo Nordisk Investigational Site
city: Wilhelmshaven
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Basel-Bruderholz
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Genève 14
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Lugano
country: Switzerland
facility: Novo Nordisk Investigational Site
city: St. Gallen
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: