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Completed

NCT Number: NCT00569400

Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes

This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases 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, Broadmeadow, 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

  • Duration of diabetes for at least 12 months
  • Basal/bolus treatment with human insulin for at least 2 months preceding trial start
  • Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
  • HbA1c lesser than or equal to 12.0%

Exclusion criteria

  • Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
  • Any condition that the investigator and/or sponsor feel would interfere with trial participation
  • Known or suspected allergy against trial product or related products

Treatment and study plan

human insulin

Drug

Primary outcomes

  1. Change of human insulin antibodies

    Time frame: after 26 weeks of treatment

Secondary outcomes

  1. Change of human insulin antibodies

  2. Frequency of adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 7, 2007
Registry last updated
Feb 27, 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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