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OpenTrials
Completed

NCT Number: NCT00600366

Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).

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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

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Belgrade, Serbia and Montenegro

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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
  • Insulin naive diabetes
  • Current treatment with OHA, secondary failure
  • Body mass index (BMI) below 40 kg/m2
  • HbA1c over 8.5%
  • Willing and able to start with insulin therapy and to perform self-blood glucose monitoring

Exclusion criteria

  • History of drug or alcohol abuse
  • Receipt of the investigational drug within the last month prior to this trial
  • Known or suspected allergy to trial products or related products
  • Severe uncontrolled hypertension
  • Any disease or condition, which the Investigator feels, would interfere with the trial

Treatment and study plan

biphasic insulin aspart

Drug

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

Primary outcomes

  1. HbA1c

    Time frame: after 12 weeks of treatment

Secondary outcomes

  1. Blood glucose profiles

  2. Incidence of hypoglycaemic episodes

  3. Incidence of adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 25, 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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