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NCT00619697 Clinical Trial

Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— EUROMIX  

Official title:
Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00619697
Other study ID # BIASP-1564
Secondary ID
Status Completed
Phase Phase 4
First received February 11, 2008
Last updated January 5, 2017
Start date December 2003
Est. completion date March 2005

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and WomenGermany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyPoland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical TrialsSlovakia: State Institute for Drug ControlPoland: The Office for Reg. of Medicinal Products, Medical Devices and Biocidal Products - Central Register of Clinical TrialsSlovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 260
Est. completion date March 2005
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart

• insulin glargine

• metformin

• glimepiride

Locations
Country Name City State
Austria Novo Nordisk Investigational Site Ebreichsdorf
Austria Novo Nordisk Investigational Site Feldkirch
Austria Novo Nordisk Investigational Site Graz
Austria Novo Nordisk Investigational Site Horn
Austria Novo Nordisk Investigational Site Oberpullendorf
Austria Novo Nordisk Investigational Site Salzburg
Austria Novo Nordisk Investigational Site Villach
Austria Novo Nordisk Investigational Site Waidhofen a.d. Thaya
Czech Republic Novo Nordisk Investigational Site Brno
Czech Republic Novo Nordisk Investigational Site Liberec
Germany Novo Nordisk Investigational Site Augsburg
Germany Novo Nordisk Investigational Site Castrop-Rauxel
Germany Novo Nordisk Investigational Site Deggingen
Germany Novo Nordisk Investigational Site Duisburg
Germany Novo Nordisk Investigational Site Erlangen
Germany Novo Nordisk Investigational Site Eschweiler
Germany Novo Nordisk Investigational Site Friedrichsthal
Germany Novo Nordisk Investigational Site Fulda
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Herne
Germany Novo Nordisk Investigational Site Kippenheim
Germany Novo Nordisk Investigational Site Lauffen
Germany Novo Nordisk Investigational Site Leverkusen
Germany Novo Nordisk Investigational Site Ludwigsburg
Germany Novo Nordisk Investigational Site Ludwigshafen
Germany Novo Nordisk Investigational Site Ludwigshafen
Germany Novo Nordisk Investigational Site Mannheim
Germany Novo Nordisk Investigational Site Mannheim
Germany Novo Nordisk Investigational Site Marburg
Germany Novo Nordisk Investigational Site Marburg
Germany Novo Nordisk Investigational Site Mülheim
Germany Novo Nordisk Investigational Site Neunkirchen
Germany Novo Nordisk Investigational Site Ostercappeln
Germany Novo Nordisk Investigational Site Pritzwalk
Germany Novo Nordisk Investigational Site Rosenheim
Germany Novo Nordisk Investigational Site Viernheim
Germany Novo Nordisk Investigational Site Weil der Stadt
Germany Novo Nordisk Investigational Site Weiskirchen
Germany Novo Nordisk Investigational Site Witten
Germany Novo Nordisk Investigational Site Witten
Hungary Novo Nordisk Investigational Site Budapest
Hungary Novo Nordisk Investigational Site Eger
Hungary Novo Nordisk Investigational Site Szekszárd
Poland Novo Nordisk Investigational Site Czestochowa
Poland Novo Nordisk Investigational Site Gdynia
Poland Novo Nordisk Investigational Site Lublin
Poland Novo Nordisk Investigational Site Otwock
Poland Novo Nordisk Investigational Site Poznan
Slovakia Novo Nordisk Investigational Site L'ubochna
Slovakia Novo Nordisk Investigational Site Martin
Slovenia Novo Nordisk Investigational Site Celje
Slovenia Novo Nordisk Investigational Site Ljubljana
Slovenia Novo Nordisk Investigational Site Maribor

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany,  Hungary,  Poland,  Slovakia,  Slovenia, 

References & Publications (1)

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 26 weeks of treatment No
Secondary HbA1c after 16 weeks of treatment No
Secondary Plasma glucose profiles No
Secondary Change in body mass index No
Secondary Incidence of hypoglycaemic episodes No
Secondary Safety profile No
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