Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble Insulin as Meal Related Insulin in a Multiple Injection Regimen in Type 1 Diabetic Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01707134

Enrollment

753

Registered

2012-10-16

Start date

1997-09-30

Completion date

2000-05-31

Last updated

2017-01-04

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. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.

Interventions

DRUGinsulin aspart

Injected subcutaneously (s.c, under the skin) as meal time insulin

DRUGhuman soluble insulin

Injected subcutaneously (s.c, under the skin) as meal time insulin

DRUGinsulin NPH

Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The subject must have completed the six month controlled treatment period in trial ANA/DCD/035

Design outcomes

Primary

Measure	Time frame
Number of hypoglycaemic events	—

Secondary

Measure	Time frame
Occurrence of adverse events	—
Incidence of hypoglycaemic episodes	—
Standard safety parameters: Haematology and biochemistry	—
HbA1c (glycosylated haemoglobin)	—

Countries

Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026