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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00832182

Enrollment

Registered

2009-01-30

Start date

1999-12-22

Completion date

2002-11-25

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief 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

Interventions

DRUGinsulin aspart

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

DRUGinsulin NPH

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Number of hypoglycemic episodes and adverse events	at 3 and 6 months and at the end of the trial

Secondary

Measure	Time frame
HbA1c	at 3 and 6 months and at the end of the trial
9-point blood glucose profile	at 3 and 6 months and at the end of the trial

Countries

Croatia, Czechia, Israel, Russia, Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026