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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00619697
First received: February 11, 2008
Last updated: January 5, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: after 16 weeks of treatment ]
  • Plasma glucose profiles
  • Change in body mass index
  • Incidence of hypoglycaemic episodes
  • Safety profile

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 54 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: 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: January 5, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Glimepiride
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Metformin
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 25, 2017