Clinical trial NCT00619697: Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes
Official title: Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 260
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 on blood glucose control in type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 6 months
* Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed
* Previous treatment with oral antidiabetic drugs for at least 4 months
* Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen
* BMI below 40 kg/m2
* HbA1c between 7-12%
* Able and willing to perform self-plasma glucose monitoring

Exclusion Criteria:

* The receipt of any other investigational drug within 4 weeks before screening
* A history of drug or alcohol abuse within the last 12 months
* Severe, uncontrolled hypertension
* Known or suspected allergy to trial products or related products

Primary outcomes:
measure: HbA1c
timeFrame: after 26 weeks of treatment
Secondary outcomes:
measure: HbA1c
timeFrame: after 16 weeks of treatment
measure: Plasma glucose profiles
measure: Change in body mass index
measure: Incidence of hypoglycaemic episodes
measure: Safety profile
Other outcomes:
Locations:
city: Ebreichsdorf
country: Austria
facility: Novo Nordisk Investigational Site
city: Feldkirch
country: Austria
facility: Novo Nordisk Investigational Site
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Horn
country: Austria
facility: Novo Nordisk Investigational Site
city: Oberpullendorf
country: Austria
facility: Novo Nordisk Investigational Site
city: Salzburg
country: Austria
facility: Novo Nordisk Investigational Site
city: Villach
country: Austria
facility: Novo Nordisk Investigational Site
city: Waidhofen a.d. Thaya
country: Austria
facility: Novo Nordisk Investigational Site
city: Brno
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Liberec
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Augsburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Castrop-Rauxel
country: Germany
facility: Novo Nordisk Investigational Site
city: Deggingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Erlangen
country: Germany
facility: Novo Nordisk Investigational Site
city: Eschweiler
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Fulda
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: Herne
country: Germany
facility: Novo Nordisk Investigational Site
city: Kippenheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Lauffen
country: Germany
facility: Novo Nordisk Investigational Site
city: Leverkusen
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigsburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: Ludwigshafen
country: Germany
facility: Novo Nordisk Investigational Site
city: Mannheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Mannheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Marburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Marburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Mülheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Neunkirchen
country: Germany
facility: Novo Nordisk Investigational Site
city: Ostercappeln
country: Germany
facility: Novo Nordisk Investigational Site
city: Pritzwalk
country: Germany
facility: Novo Nordisk Investigational Site
city: Rosenheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Viernheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Weil der Stadt
country: Germany
facility: Novo Nordisk Investigational Site
city: Weiskirchen
country: Germany
facility: Novo Nordisk Investigational Site
city: Witten
country: Germany
facility: Novo Nordisk Investigational Site
city: Witten
country: Germany
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Eger
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szekszárd
country: Hungary
facility: Novo Nordisk Investigational Site
city: Czestochowa
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdynia
country: Poland
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Otwock
country: Poland
facility: Novo Nordisk Investigational Site
city: Poznan
country: Poland
facility: Novo Nordisk Investigational Site
city: L'ubochna
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Martin
country: Slovakia
facility: Novo Nordisk Investigational Site
city: Celje
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Ljubljana
country: Slovenia
facility: Novo Nordisk Investigational Site
city: Maribor
country: Slovenia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kann PH, Wascher T, Zackova V, Moeller J, Medding J, Szocs A, Mokan M, Mrevlje F, Regulski M. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):527-32. doi: 10.1055/s-2006-949655.