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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00619697
First received: February 11, 2008
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart
Drug: insulin glargine
Drug: metformin
Drug: glimepiride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
  • Plasma glucose profiles [ Designated as safety issue: No ]
  • Change in body mass index [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Safety profile [ Designated as safety issue: No ]

Enrollment: 260
Study Start Date: December 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: biphasic insulin aspart
    Other Names:
    • BIASP
    • NovoMix 30
    • NovoLog 70/30 Mix
    Drug: insulin glargine Drug: metformin Drug: glimepiride
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619697

Locations
Austria
Graz, Austria, 8036
Czech Republic
Brno, Czech Republic, 65691
Germany
Marburg, Germany, 35043
Hungary
Budapest, Hungary, 1041
Poland
Otwock, Poland, 05-400
Slovakia
Martin, Slovakia, 036 59
Slovenia
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Plamen Kozlovski Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00619697     History of Changes
Other Study ID Numbers: BIASP-1564
Study First Received: February 11, 2008
Last Updated: June 15, 2012
Health Authority: Austria: Federal Ministry for Health and Women
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials
Slovakia: State Institute for Drug Control
Poland: The Office for Reg. of Medicinal Products, Medical Devices and Biocidal Products - Central Register of Clinical Trials
Slovenia: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Insulin aspart
Glargine
Insulin
Metformin
 Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013