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OpenTrials
Completed

NCT Number: NCT00600626

Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment 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 3

Primary location

Novo Nordisk Investigational Site, Zagreb, Croatia

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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
  • Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
  • HbA1c between 8.0-10.5%
  • Body mass index (BMI) below 35.0 kg/m2
  • Able and willing to perform self-monitoring of blood glucose

Exclusion criteria

  • Total daily insulin dose of 1.80 IU/kg or more
  • Known or suspected allergy to trial product or related products
  • Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

Treatment and study plan

biphasic insulin aspart

Drug

insulin NPH

Drug

insulin aspart

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 4 months of treatment

Secondary outcomes

  1. 8-point blood glucose profile

  2. incidence of hypoglycaemic episodes

  3. safety profiles

  4. changes in body weight and vital signs

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
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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