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

• Status: Completed
• Trial end date: 2002-11-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting; Isophane insulin, beef; Isophane Insulin, Human

Criteria

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