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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin NPH; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00832182

ANA-1229

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Insulin aspart and neutral protamine Hagedorn insulin

Experimental group

Treatment:

Drug: insulin NPH

Drug: insulin aspart