DiabetesPhase 3NCT00832182
Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes
A Phase 3 study testing insulin aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 10 sites in 5 countries.
Trial summary
This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/065 trial Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin aspart and insulin NPH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 22 Dec 1999to 25 Nov 2002
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
- The subject must have completed the ANA/DCD/065 trial
Who cannot join
- Impaired hepatic function
- Impaired renal function
- Total daily insulin requirements of more than 1.4 U/kg
- Cardiac problems
- Uncontrolled hypertension
- Known or suspected allergy to trial product or related products
Show all 10Show fewer
- Current hypoglycaemic unawareness as judged by the investigator
- Known or suspect abuse of alcohol or narcotics
- Women breastfeeding or having the intention of becoming pregnant, or if judged not to be using adequate contraceptive measures (adequate measures are intrauterine device (IUD), oral contraception and barrier methods)
- Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Russia5 sites
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 119435
Novo Nordisk Investigational Site
Moscow, 125315
Novo Nordisk Investigational Site
Moscow, 129110
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Czechia2 sites
Novo Nordisk Investigational Site
Prague, 10034
Novo Nordisk Investigational Site
Prague, 12821
About this study
Official title: An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen
This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/065 trial
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin aspart, 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
Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day
insulin NPHDrug
Insulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day
| Study group | Role | What they receive |
|---|---|---|
| Insulin aspart and neutral protamine Hagedorn insulin | Experimental | Not described Receives: Drug: insulin aspart; Drug: insulin NPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoglycemic episodes and adverse events
Measured: at 3 and 6 months and at the end of the trial
Secondary outcomes (2)
HbA1c
Measured: at 3 and 6 months and at the end of the trial
9-point blood glucose profile
Measured: at 3 and 6 months and at the end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study start22 Dec 1999
- Primary completion25 Nov 2002
- Study completion25 Nov 2002
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT00832182
- Sponsor's protocol ID
- ANA-1229
- Status last verified
- Feb 2017
- First submitted
- 29 Jan 2009
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cada DJ, Levien T, Baker DE. Insulin aspart. Hospital Pharmacy 2000; 35: 1221-1229
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen
- ClinicalTrials.gov ID
- NCT00832182
- Acronym / sponsor ID
- ANA-1229
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 1999 (actual)
- Primary completion
- 25 Nov 2002 (actual)
- Study completion
- 25 Nov 2002 (actual)
- First posted
- 30 Jan 2009 (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 and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/065 trial
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin aspart and neutral protamine Hagedorn insulin | Experimental | Drug: insulin aspart, Drug: insulin NPH |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
- The subject must have completed the ANA/DCD/065 trial
Key exclusion criteria (10 listed)
- Impaired hepatic function
- Impaired renal function
- Total daily insulin requirements of more than 1.4 U/kg
- Cardiac problems
- Uncontrolled hypertension
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 aspartInsulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day | Drug | Insulin aspart and neutral protamine Hagedorn insulin |
| insulin NPHInsulin aspart at breakfast, lunch and dinner time. Neutral protamine Hagedorn insulin at breakfast, lunch, dinner and bedtime. Injections were optional but at least one injection per day | Drug | Insulin aspart and neutral protamine Hagedorn insulin |
Primary outcome
Number of hypoglycemic episodes and adverse events
Time frame: at 3 and 6 months and at the end of the trial
2 secondary outcomes
HbA1c
Time frame: at 3 and 6 months and at the end of the trial
9-point blood glucose profile
Time frame: at 3 and 6 months and at the end of the trial
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 23 Feb 2017.
- Results publicationCada DJ, Levien T, Baker DE. Insulin aspart. Hospital Pharmacy 2000; 35: 1221-1229
- 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
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 10 sites in 5 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 2 inclusion and 10 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Russia, Czechia, Croatia, Israel, Slovenia. 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 hypoglycemic episodes and adverse events (time frame: at 3 and 6 months and at the end of the trial). 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 NCT00832182, 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 23 Feb 2017.