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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 A/S
ClinicalTrials.gov Identifier:
NCT00619697
First received: February 11, 2008
Last updated: June 15, 2012
Last verified: June 2012
  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:


Further study details as provided by Novo Nordisk A/S:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
Investigators
Study Director: Plamen Kozlovski Novo Nordisk A/S
  More Information

Additional Information:
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Glargine
Glimepiride
Insulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Globin Zinc
Insulin, Isophane
Metformin
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014