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Completed

NCT Number: NCT00605111

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

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes failing OAD therapy.

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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, Blacktown, New South Wales, Australia

Loading trial locations.

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 24 months
  • BMI between 18 and 30 kg/m2
  • Insulin naive subjects
  • OAD treatment with max two OADs alone or combined with other therapy
  • HbA1c between 7-12%

Exclusion criteria

  • Type 1 diabetes
  • Receipt of any investigational drug within the last three months prior to this trial
  • Current or previous treatment with thiazolidiones within the last 6 months
  • OAD treatment with three or more OADs within the last 4 months

Treatment and study plan

biphasic insulin aspart

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 11 weeks of treatment

Secondary outcomes

  1. The proportion of subjects achieving treatment target of HbA1c below 7%

    Time frame: at 11 and 24 weeks

  2. 8-point plasma glucose profiles

    Time frame: performed at 11 and 24 weeks

  3. FPG

    Time frame: at 11 weeks and 24 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jan 30, 2008
Registry last updated
Jan 11, 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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