DiabetesPhase 3NCT01707134
Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes
A Phase 3 study testing insulin aspart, human soluble insulin and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 80 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin aspart, human soluble insulin and insulin NPH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 753 participants
- Where
- 80 sitesin 8 countries
- Study dates
- Sep 1997to May 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must have completed the six month controlled treatment period in trial ANA/DCD/035
Who cannot join
None listed.
Trial locations and contacts
80 sites in 8 countries.
80 sites in 8 countries
United Kingdom32 sites
Novo Nordisk Investigational Site
Airdrie, ML6 0JS
Novo Nordisk Investigational Site
Bath, BA1 3NG
Novo Nordisk Investigational Site
Blackburn, BB3 3LR
Novo Nordisk Investigational Site
Bolton, BL1 4QS
Novo Nordisk Investigational Site
Church Village, CF38 1AB
Novo Nordisk Investigational Site
Cosham, PO6 3LY
Novo Nordisk Investigational Site
Coventry, CV1 4FH
Novo Nordisk Investigational Site
Edinburgh, EH16 4SA
Novo Nordisk Investigational Site
Edinburgh, EH4 2XU
Novo Nordisk Investigational Site
Exeter, EX2 5AX
Novo Nordisk Investigational Site
Gillingham, ME7 5NY
Novo Nordisk Investigational Site
Hull, HU3 2JZ
Novo Nordisk Investigational Site
Inverness, IV2 3UJ
Novo Nordisk Investigational Site
Leicester, LE1 5WW
Novo Nordisk Investigational Site
London, E1 1BB
Novo Nordisk Investigational Site
Middlesbrough, TS5 5AZ
Novo Nordisk Investigational Site
Newcastle, NE7 7DN
Novo Nordisk Investigational Site
Northampton, NN1 5BD
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Penarth, CF64 2XX
Novo Nordisk Investigational Site
Plymouth, PL8 8DQ
Novo Nordisk Investigational Site
Reading, RG51 5BS
Novo Nordisk Investigational Site
Rugby, CV22 5PX
Novo Nordisk Investigational Site
Salisbury, SP2 8BJ
Novo Nordisk Investigational Site
Sheffield, S5 7AU
Novo Nordisk Investigational Site
Southampton, SO14 OYG
Novo Nordisk Investigational Site
Stevenage, SG1 4AB
Novo Nordisk Investigational Site
Stirling, FK8 2AU
Novo Nordisk Investigational Site
Swansea, SA6 6NL
Novo Nordisk Investigational Site
Watford, WD18 0HB
Novo Nordisk Investigational Site
Whiston, L35 5DR
Novo Nordisk Investigational Site
York, YO3 7HE
Germany28 sites
Novo Nordisk Investigational Site
Bad Neuenahr-Ahrweiler, 53474
Novo Nordisk Investigational Site
Bad Oeynhausen, 32454
Novo Nordisk Investigational Site
Bochum, 44789
Novo Nordisk Investigational Site
Essen, 45131
Novo Nordisk Investigational Site
Essen, 45138
Novo Nordisk Investigational Site
Flensburg, 24939
Novo Nordisk Investigational Site
Frankfurt, 60590
Novo Nordisk Investigational Site
Freiburg im Breisgau, 79106
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Giessen, 35385
Novo Nordisk Investigational Site
Haan, 42781
Novo Nordisk Investigational Site
Hamburg, 20251
Novo Nordisk Investigational Site
Kiel, 24103
Novo Nordisk Investigational Site
Magdeburg, 39120
Novo Nordisk Investigational Site
Magdeburg, 39124
Novo Nordisk Investigational Site
Mainz, 55116
Novo Nordisk Investigational Site
Mainz, 55131
Novo Nordisk Investigational Site
Mönchengladbach, 41061
Novo Nordisk Investigational Site
München, 81925
Novo Nordisk Investigational Site
Oberhausen, 46145
Novo Nordisk Investigational Site
Ostercappeln, 49179
Novo Nordisk Investigational Site
Saarlouis, 66740
Novo Nordisk Investigational Site
Schwerin, 19049
Novo Nordisk Investigational Site
Stuttgart, 70184
Novo Nordisk Investigational Site
Stuttgart, 70191
Novo Nordisk Investigational Site
Wiesbaden, 65191
Novo Nordisk Investigational Site
Wuppertal, 42117
Novo Nordisk Investigational Site
Würzburg, 97070
Denmark5 sites
Novo Nordisk Investigational Site
Copenhagen, 2400
Novo Nordisk Investigational Site
Frederiksberg, 2000
Novo Nordisk Investigational Site
Gentofte Municipality, 2820
Novo Nordisk Investigational Site
Køge, 4600
Novo Nordisk Investigational Site
Kolding, 6000
Norway5 sites
Novo Nordisk Investigational Site
Bergen, 5021
Novo Nordisk Investigational Site
Haugesund, 5500
Novo Nordisk Investigational Site
Oslo, 0407
Novo Nordisk Investigational Site
Stavanger, 4011
Novo Nordisk Investigational Site
Trondheim, 7006
Finland4 sites
Novo Nordisk Investigational Site
Helsinki, 00029
Novo Nordisk Investigational Site
Kotka, 48210
Novo Nordisk Investigational Site
Kuopio, 70210
Novo Nordisk Investigational Site
Vantaa, 01400
Austria3 sites
Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, 1090
Sweden2 sites
Novo Nordisk Investigational Site
Falun, 791 82
Novo Nordisk Investigational Site
Karlstad, 651 85
About this study
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
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin aspart, human soluble insulin, insulin NPH
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin aspartDrug
Injected subcutaneously (s.c, under the skin) as meal time insulin
human soluble insulinDrug
Injected subcutaneously (s.c, under the skin) as meal time insulin
insulin NPHDrug
Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin
| Study group | Role | What they receive |
|---|---|---|
| insulin aspart | Experimental | Not described Receives: Drug: insulin aspart; Drug: insulin NPH |
| human insulin | Active comparator | Not described Receives: Drug: human soluble insulin; Drug: insulin NPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoglycaemic events
Secondary outcomes (4)
Occurrence of adverse events
Incidence of hypoglycaemic episodes
Standard safety parameters: Haematology and biochemistry
HbA1c (glycosylated haemoglobin)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startSep 1997
- Primary completionMay 2000
- Study completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 753 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR,1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707134
- Sponsor's protocol ID
- ANA/DCD/050
- Status last verified
- Jan 2017
- First submitted
- 10 Oct 2012
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01707134
- Acronym / sponsor ID
- ANA/DCD/050
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 753 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 1997
- Primary completion
- May 2000 (actual)
- Study completion
- May 2000 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin aspart | Experimental | Drug: insulin aspart, Drug: insulin NPH |
| human insulin | Active comparator | Drug: human soluble insulin, Drug: insulin NPH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subject must have completed the six month controlled treatment period in trial ANA/DCD/035
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin aspartInjected subcutaneously (s.c, under the skin) as meal time insulin | Drug | insulin aspart |
| human soluble insulinInjected subcutaneously (s.c, under the skin) as meal time insulin | Drug | human insulin |
| insulin NPHWill be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin | Drug | human insulin, insulin aspart |
Primary outcome
Number of hypoglycaemic events
4 secondary outcomes
Occurrence of adverse events
Incidence of hypoglycaemic episodes
Standard safety parameters: Haematology and biochemistry
HbA1c (glycosylated haemoglobin)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Results publication: PubMed 16054266Home 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR,1452) study director
Novo Nordisk A/S
80 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin aspart, human soluble insulin and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 80 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United Kingdom, Germany, Denmark, Norway, Finland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypoglycaemic events. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01707134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.