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

January 3, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

753

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
      • Wien, Austria, 1030
        • Novo Nordisk Investigational Site
  • Denmark
      • Frederiksberg, Denmark, 2000
        • Novo Nordisk Investigational Site
      • Gentofte, Denmark, 2820
        • Novo Nordisk Investigational Site
      • Kolding, Denmark, 6000
        • Novo Nordisk Investigational Site
      • København, Denmark, 2400
        • Novo Nordisk Investigational Site
      • Køge, Denmark, 4600
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • Novo Nordisk Investigational Site
      • Kotka, Finland, 48210
        • Novo Nordisk Investigational Site
      • Kuopio, Finland, 70210
        • Novo Nordisk Investigational Site
      • Vantaa, Finland, 01400
        • Novo Nordisk Investigational Site
  • Germany
      • Bad Neuenahr-Ahrweiler, Germany, 53474
        • Novo Nordisk Investigational Site
      • Bad Oeynhausen, Germany, 32454
        • Novo Nordisk Investigational Site
      • Bochum, Germany, 44789
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45138
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45131
        • Novo Nordisk Investigational Site
      • Flensburg, Germany, 24939
        • Novo Nordisk Investigational Site
      • Frankfurt, Germany, 60590
        • Novo Nordisk Investigational Site
      • Freiburg, Germany, 79106
        • Novo Nordisk Investigational Site
      • Friedrichsthal, Germany, 66299
        • Novo Nordisk Investigational Site
      • Giessen, Germany, 35385
        • Novo Nordisk Investigational Site
      • Haan, Germany, 42781
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 20251
        • Novo Nordisk Investigational Site
      • Kiel, Germany, 24103
        • Novo Nordisk Investigational Site
      • Magdeburg, Germany, 39120
        • Novo Nordisk Investigational Site
      • Magdeburg, Germany, 39124
        • Novo Nordisk Investigational Site
      • Mainz, Germany, 55116
        • Novo Nordisk Investigational Site
      • Mainz, Germany, 55131
        • Novo Nordisk Investigational Site
      • Mönchengladbach, Germany, 41061
        • Novo Nordisk Investigational Site
      • München, Germany, 81925
        • Novo Nordisk Investigational Site
      • Oberhausen, Germany, 46145
        • Novo Nordisk Investigational Site
      • Ostercappeln, Germany, 49179
        • Novo Nordisk Investigational Site
      • Saarlouis, Germany, 66740
        • Novo Nordisk Investigational Site
      • Schwerin, Germany, 19049
        • Novo Nordisk Investigational Site
      • Stuttgart, Germany, 70184
        • Novo Nordisk Investigational Site
      • Stuttgart, Germany, 70191
        • Novo Nordisk Investigational Site
      • Wiesbaden, Germany, 65191
        • Novo Nordisk Investigational Site
      • Wuppertal, Germany, 42117
        • Novo Nordisk Investigational Site
      • Würzburg, Germany, 97070
        • Novo Nordisk Investigational Site
  • Norway
      • Bergen, Norway, 5021
        • Novo Nordisk Investigational Site
      • Haugesund, Norway, 5500
        • Novo Nordisk Investigational Site
      • Oslo, Norway, 0407
        • Novo Nordisk Investigational Site
      • Stavanger, Norway, 4011
        • Novo Nordisk Investigational Site
      • Trondheim, Norway, 7006
        • Novo Nordisk Investigational Site
  • Sweden
      • Falun, Sweden, 791 82
        • Novo Nordisk Investigational Site
      • Karlstad, Sweden, 651 85
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8032
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Airdrie, United Kingdom, ML6 0JS
        • Novo Nordisk Investigational Site
      • Bath, United Kingdom, BA1 3NG
        • Novo Nordisk Investigational Site
      • Blackburn, United Kingdom, BB3 3LR
        • Novo Nordisk Investigational Site
      • Bolton, United Kingdom, BL1 4QS
        • Novo Nordisk Investigational Site
      • Church Village, United Kingdom, CF38 1AB
        • Novo Nordisk Investigational Site
      • Cosham, United Kingdom, PO6 3LY
        • Novo Nordisk Investigational Site
      • Coventry, United Kingdom, CV1 4FH
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom, EH16 4SA
        • Novo Nordisk Investigational Site
      • Exeter, United Kingdom, EX2 5AX
        • Novo Nordisk Investigational Site
      • Gillingham, United Kingdom, ME7 5NY
        • Novo Nordisk Investigational Site
      • Hull, United Kingdom, HU3 2JZ
        • Novo Nordisk Investigational Site
      • Inverness, United Kingdom, IV2 3UJ
        • Novo Nordisk Investigational Site
      • Leicester, United Kingdom, LE1 5WW
        • Novo Nordisk Investigational Site
      • London, United Kingdom, E1 1BB
        • Novo Nordisk Investigational Site
      • Middlesbrough, United Kingdom, TS5 5AZ
        • Novo Nordisk Investigational Site
      • Newcastle, United Kingdom, NE7 7DN
        • Novo Nordisk Investigational Site
      • Northampton, United Kingdom, NN1 5BD
        • Novo Nordisk Investigational Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novo Nordisk Investigational Site
      • Penarth, United Kingdom, CF64 2XX
        • Novo Nordisk Investigational Site
      • Plymouth, United Kingdom, PL8 8DQ
        • Novo Nordisk Investigational Site
      • Reading, United Kingdom, RG51 5BS
        • Novo Nordisk Investigational Site
      • Rugby, United Kingdom, CV22 5PX
        • Novo Nordisk Investigational Site
      • Salisbury, United Kingdom, SP2 8BJ
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Novo Nordisk Investigational Site
      • Southampton, United Kingdom, SO14 OYG
        • Novo Nordisk Investigational Site
      • Stevenage, United Kingdom, SG1 4AB
        • Novo Nordisk Investigational Site
      • Stirling, United Kingdom, FK8 2AU
        • Novo Nordisk Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • Novo Nordisk Investigational Site
      • Watford, United Kingdom, WD18 0HB
        • Novo Nordisk Investigational Site
      • Whiston, United Kingdom, L35 5DR
        • Novo Nordisk Investigational Site
      • York, United Kingdom, YO3 7HE
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: insulin aspart
Drug: insulin aspart
Injected subcutaneously (s.c, under the skin) as meal time insulin
Drug: insulin NPH
Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin
Active Comparator: human insulin
Drug: insulin NPH
Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin
Drug: human soluble insulin
Injected subcutaneously (s.c, under the skin) as meal time insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of hypoglycaemic events

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1997

Primary Completion (Actual)

May 1, 2000

Study Completion (Actual)

May 1, 2000

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA/DCD/050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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