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Completed

NCT Number: NCT00619697

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

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

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Ebreichsdorf, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart

Drug

Other names: BIASP, NovoMix 30, NovoLog 70/30 Mix

insulin glargine

Drug

metformin

Drug

Glimepiride

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 26 weeks of treatment

Secondary outcomes

  1. HbA1c

    Time frame: after 16 weeks of treatment

  2. Plasma glucose profiles

  3. Change in body mass index

  4. Incidence of hypoglycaemic episodes

  5. Safety profile

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: EUROMIX

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Feb 21, 2008
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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