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NCT01707134 Clinical Trial

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

Diabetes Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01707134
Other study ID # ANA/DCD/050
Secondary ID
Status Completed
Phase Phase 3
First received October 10, 2012
Last updated January 3, 2017
Start date September 1997
Est. completion date May 2000

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesNorway: Norwegian Medicines AgencySweden: Medical Products AgencySwitzerland: Federal Office of Public HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 753
Est. completion date May 2000
Est. primary completion date May 2000
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• insulin aspart
Injected subcutaneously (s.c, under the skin) as meal time insulin
• human soluble insulin
Injected subcutaneously (s.c, under the skin) as meal time insulin
• insulin NPH
Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin

Locations
Country Name City State
Austria Novo Nordisk Investigational Site Graz
Austria Novo Nordisk Investigational Site Wien
Austria Novo Nordisk Investigational Site Wien
Denmark Novo Nordisk Investigational Site Frederiksberg
Denmark Novo Nordisk Investigational Site Gentofte
Denmark Novo Nordisk Investigational Site København
Denmark Novo Nordisk Investigational Site Køge
Denmark Novo Nordisk Investigational Site Kolding
Finland Novo Nordisk Investigational Site Helsinki
Finland Novo Nordisk Investigational Site Kotka
Finland Novo Nordisk Investigational Site Kuopio
Finland Novo Nordisk Investigational Site Vantaa
Germany Novo Nordisk Investigational Site Bad Neuenahr-Ahrweiler
Germany Novo Nordisk Investigational Site Bad Oeynhausen
Germany Novo Nordisk Investigational Site Bochum
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Flensburg
Germany Novo Nordisk Investigational Site Frankfurt
Germany Novo Nordisk Investigational Site Freiburg
Germany Novo Nordisk Investigational Site Friedrichsthal
Germany Novo Nordisk Investigational Site Giessen
Germany Novo Nordisk Investigational Site Haan
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Kiel
Germany Novo Nordisk Investigational Site Magdeburg
Germany Novo Nordisk Investigational Site Magdeburg
Germany Novo Nordisk Investigational Site Mainz
Germany Novo Nordisk Investigational Site Mainz
Germany Novo Nordisk Investigational Site Mönchengladbach
Germany Novo Nordisk Investigational Site München
Germany Novo Nordisk Investigational Site Oberhausen
Germany Novo Nordisk Investigational Site Ostercappeln
Germany Novo Nordisk Investigational Site Saarlouis
Germany Novo Nordisk Investigational Site Schwerin
Germany Novo Nordisk Investigational Site Stuttgart
Germany Novo Nordisk Investigational Site Stuttgart
Germany Novo Nordisk Investigational Site Wiesbaden
Germany Novo Nordisk Investigational Site Wuppertal
Germany Novo Nordisk Investigational Site Würzburg
Norway Novo Nordisk Investigational Site Bergen
Norway Novo Nordisk Investigational Site Haugesund
Norway Novo Nordisk Investigational Site Oslo
Norway Novo Nordisk Investigational Site Stavanger
Norway Novo Nordisk Investigational Site Trondheim
Sweden Novo Nordisk Investigational Site Falun
Sweden Novo Nordisk Investigational Site Karlstad
Switzerland Novo Nordisk Investigational Site Zürich
United Kingdom Novo Nordisk Investigational Site Airdrie
United Kingdom Novo Nordisk Investigational Site Bath
United Kingdom Novo Nordisk Investigational Site Blackburn
United Kingdom Novo Nordisk Investigational Site Bolton
United Kingdom Novo Nordisk Investigational Site Church Village
United Kingdom Novo Nordisk Investigational Site Cosham
United Kingdom Novo Nordisk Investigational Site Coventry
United Kingdom Novo Nordisk Investigational Site Edinburgh
United Kingdom Novo Nordisk Investigational Site Edinburgh
United Kingdom Novo Nordisk Investigational Site Exeter
United Kingdom Novo Nordisk Investigational Site Gillingham
United Kingdom Novo Nordisk Investigational Site Hull
United Kingdom Novo Nordisk Investigational Site Inverness
United Kingdom Novo Nordisk Investigational Site Leicester
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Middlesbrough
United Kingdom Novo Nordisk Investigational Site Newcastle
United Kingdom Novo Nordisk Investigational Site Northampton
United Kingdom Novo Nordisk Investigational Site Nottingham
United Kingdom Novo Nordisk Investigational Site Penarth
United Kingdom Novo Nordisk Investigational Site Plymouth
United Kingdom Novo Nordisk Investigational Site Reading
United Kingdom Novo Nordisk Investigational Site Rugby
United Kingdom Novo Nordisk Investigational Site Salisbury
United Kingdom Novo Nordisk Investigational Site Sheffield
United Kingdom Novo Nordisk Investigational Site Southampton
United Kingdom Novo Nordisk Investigational Site Stevenage
United Kingdom Novo Nordisk Investigational Site Stirling
United Kingdom Novo Nordisk Investigational Site Swansea
United Kingdom Novo Nordisk Investigational Site Watford
United Kingdom Novo Nordisk Investigational Site Whiston
United Kingdom Novo Nordisk Investigational Site York

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

References & Publications (1)

Home PD, Hallgren P, Usadel KH, Sane T, Faber J, Grill V, Friberg HH. Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes. Diabetes Res Clin Pract. 2006 Feb;71(2):131-9. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of hypoglycaemic events No
Secondary Occurrence of adverse events No
Secondary Incidence of hypoglycaemic episodes No
Secondary Standard safety parameters: Haematology and biochemistry No
Secondary HbA1c (glycosylated haemoglobin) No
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