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CompletedNCT01707134Updated Jan 4, 2017

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

A Phase 3 interventional study of insulin aspart and human soluble insulin in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 80 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-04.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
753
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 753 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • The subject must have completed the six month controlled treatment period in trial ANA/DCD/035
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
753 participants (actual)

Study arms

  • Experimental
    insulin aspart

    Drug: insulin aspart · Drug: insulin NPH

  • Active comparator
    human insulin

    Drug: human soluble insulin · Drug: insulin NPH

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

06

What researchers measure

Primary outcomes

  1. Number of hypoglycaemic events

Secondary outcomes

  1. Occurrence of adverse events

  2. Incidence of hypoglycaemic episodes

  3. Standard safety parameters: Haematology and biochemistry

  4. HbA1c (glycosylated haemoglobin)

07

Study locations

80 sites
  • Novo Nordisk Investigational Site
    Graz, 8036, Austria
  • Novo Nordisk Investigational Site
    Wien, 1030, Austria
  • Novo Nordisk Investigational Site
    Wien, 1090, Austria
  • Novo Nordisk Investigational Site
    Frederiksberg, 2000, Denmark
  • Novo Nordisk Investigational Site
    Gentofte, 2820, Denmark
  • Novo Nordisk Investigational Site
    Kolding, 6000, Denmark
  • Novo Nordisk Investigational Site
    København, 2400, Denmark
  • Novo Nordisk Investigational Site
    Køge, 4600, Denmark
  • Novo Nordisk Investigational Site
    Helsinki, 00029, Finland
  • Novo Nordisk Investigational Site
    Kotka, 48210, Finland
  • Novo Nordisk Investigational Site
    Kuopio, 70210, Finland
  • Novo Nordisk Investigational Site
    Vantaa, 01400, Finland
  • Novo Nordisk Investigational Site
    Bad Neuenahr-Ahrweiler, 53474, Germany
  • Novo Nordisk Investigational Site
    Bad Oeynhausen, 32454, Germany
  • Novo Nordisk Investigational Site
    Bochum, 44789, Germany
  • Novo Nordisk Investigational Site
    Essen, 45131, Germany
  • Novo Nordisk Investigational Site
    Essen, 45138, Germany
  • Novo Nordisk Investigational Site
    Flensburg, 24939, Germany
  • Novo Nordisk Investigational Site
    Frankfurt, 60590, Germany
  • Novo Nordisk Investigational Site
    Freiburg, 79106, Germany
  • Novo Nordisk Investigational Site
    Friedrichsthal, 66299, Germany
  • Novo Nordisk Investigational Site
    Giessen, 35385, Germany
  • Novo Nordisk Investigational Site
    Haan, 42781, Germany
  • Novo Nordisk Investigational Site
    Hamburg, 20251, Germany
  • Novo Nordisk Investigational Site
    Kiel, 24103, Germany
  • Novo Nordisk Investigational Site
    Magdeburg, 39120, Germany
  • Novo Nordisk Investigational Site
    Magdeburg, 39124, Germany
  • Novo Nordisk Investigational Site
    Mainz, 55116, Germany
  • Novo Nordisk Investigational Site
    Mainz, 55131, Germany
  • Novo Nordisk Investigational Site
    Mönchengladbach, 41061, Germany
  • Novo Nordisk Investigational Site
    München, 81925, Germany
  • Novo Nordisk Investigational Site
    Oberhausen, 46145, Germany
  • Novo Nordisk Investigational Site
    Ostercappeln, 49179, Germany
  • Novo Nordisk Investigational Site
    Saarlouis, 66740, Germany
  • Novo Nordisk Investigational Site
    Schwerin, 19049, Germany
  • Novo Nordisk Investigational Site
    Stuttgart, 70184, Germany
  • Novo Nordisk Investigational Site
    Stuttgart, 70191, Germany
  • Novo Nordisk Investigational Site
    Wiesbaden, 65191, Germany
  • Novo Nordisk Investigational Site
    Wuppertal, 42117, Germany
  • Novo Nordisk Investigational Site
    Würzburg, 97070, Germany
  • Novo Nordisk Investigational Site
    Bergen, 5021, Norway
  • Novo Nordisk Investigational Site
    Haugesund, 5500, Norway
  • Novo Nordisk Investigational Site
    Oslo, 0407, Norway
  • Novo Nordisk Investigational Site
    Stavanger, 4011, Norway
  • Novo Nordisk Investigational Site
    Trondheim, 7006, Norway
  • Novo Nordisk Investigational Site
    Falun, 791 82, Sweden
  • Novo Nordisk Investigational Site
    Karlstad, 651 85, Sweden
  • Novo Nordisk Investigational Site
    Zürich, 8032, Switzerland
  • Novo Nordisk Investigational Site
    Airdrie, ML6 0JS, United Kingdom
  • Novo Nordisk Investigational Site
    Bath, BA1 3NG, United Kingdom
  • Novo Nordisk Investigational Site
    Blackburn, BB3 3LR, United Kingdom
  • Novo Nordisk Investigational Site
    Bolton, BL1 4QS, United Kingdom
  • Novo Nordisk Investigational Site
    Church Village, CF38 1AB, United Kingdom
  • Novo Nordisk Investigational Site
    Cosham, PO6 3LY, United Kingdom
  • Novo Nordisk Investigational Site
    Coventry, CV1 4FH, United Kingdom
  • Novo Nordisk Investigational Site
    Edinburgh, EH16 4SA, United Kingdom
  • Novo Nordisk Investigational Site
    Edinburgh, EH4 2XU, United Kingdom
  • Novo Nordisk Investigational Site
    Exeter, EX2 5AX, United Kingdom
  • Novo Nordisk Investigational Site
    Gillingham, ME7 5NY, United Kingdom
  • Novo Nordisk Investigational Site
    Hull, HU3 2JZ, United Kingdom
  • Novo Nordisk Investigational Site
    Inverness, IV2 3UJ, United Kingdom
  • Novo Nordisk Investigational Site
    Leicester, LE1 5WW, United Kingdom
  • Novo Nordisk Investigational Site
    London, E1 1BB, United Kingdom
  • Novo Nordisk Investigational Site
    Middlesbrough, TS5 5AZ, United Kingdom
  • Novo Nordisk Investigational Site
    Newcastle, NE7 7DN, United Kingdom
  • Novo Nordisk Investigational Site
    Northampton, NN1 5BD, United Kingdom
  • Novo Nordisk Investigational Site
    Nottingham, NG7 2UH, United Kingdom
  • Novo Nordisk Investigational Site
    Penarth, CF64 2XX, United Kingdom
  • Novo Nordisk Investigational Site
    Plymouth, PL8 8DQ, United Kingdom
  • Novo Nordisk Investigational Site
    Reading, RG51 5BS, United Kingdom
  • Novo Nordisk Investigational Site
    Rugby, CV22 5PX, United Kingdom
  • Novo Nordisk Investigational Site
    Salisbury, SP2 8BJ, United Kingdom
  • Novo Nordisk Investigational Site
    Sheffield, S5 7AU, United Kingdom
  • Novo Nordisk Investigational Site
    Southampton, SO14 OYG, United Kingdom
  • Novo Nordisk Investigational Site
    Stevenage, SG1 4AB, United Kingdom
  • Novo Nordisk Investigational Site
    Stirling, FK8 2AU, United Kingdom
  • Novo Nordisk Investigational Site
    Swansea, SA6 6NL, United Kingdom
  • Novo Nordisk Investigational Site
    Watford, WD18 0HB, United Kingdom
  • Novo Nordisk Investigational Site
    Whiston, L35 5DR, United Kingdom
  • Novo Nordisk Investigational Site
    York, YO3 7HE, United Kingdom
08

References and documents

Publications

  • 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. doi: 10.1016/j.diabres.2005.05.015. Epub 2005 Jul 27. PubMed 16054266 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01707134
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 16, 2012
Start date
Sep 1997
Primary completion
May 2000
Completion
May 2000
Last update
Jan 4, 2017

Study contacts

Global Clinical Registry (GCR,1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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