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Completed

NCT Number: NCT00832182

Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes

This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/065 trial

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Zagreb, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • The subject must have completed the ANA/DCD/065 trial

Exclusion criteria

  • Impaired hepatic function
  • Impaired renal function
  • Total daily insulin requirements of more than 1.4 U/kg
  • Cardiac problems
  • Uncontrolled hypertension
  • Known or suspected allergy to trial product or related products
  • Current hypoglycaemic unawareness as judged by the investigator
  • Known or suspect abuse of alcohol or narcotics
  • Women breastfeeding or having the intention of becoming pregnant, or if judged not to be using adequate contraceptive measures (adequate measures are intrauterine device (IUD), oral contraception and barrier methods)
  • Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results

Treatment and study plan

insulin aspart

Drug

Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day

insulin NPH

Drug

Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day

Primary outcomes

  1. Number of hypoglycemic episodes and adverse events

    Time frame: at 3 and 6 months and at the end of the trial

Secondary outcomes

  1. HbA1c

    Time frame: at 3 and 6 months and at the end of the trial

  2. 9-point blood glucose profile

    Time frame: at 3 and 6 months and at the end of the trial

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen

Important dates

Study start
1999
Primary completion
2002
Study completion
2002
First posted
Jan 30, 2009
Registry last updated
Feb 23, 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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