DiabetesPhase 4NCT01467141
Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes
A Phase 4 study testing insulin aspart, human insulin and isophane human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 6 sites in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin aspart, human insulin and isophane human insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesGermany
- Study dates
- 19 Jun 2002to 15 Oct 2003
- Phase
- Phase 4
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes
- Treatment with insulin for at least 6 months prior to inclusion
- HbA1c below or equal to 11.0 %
- Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion
Who cannot join
- The receipt of any investigational drug within one month prior to this trial
- Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
- Total daily insulin doses at least 1.80 IU/kg
- Treatment with oral hypoglycaemic agents
- Known or suspected allergy to trial product or related products
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Novo Nordisk Investigational Site
Berlin, 13353
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Hagen, 58095
Novo Nordisk Investigational Site
Hamburg, 22149
Novo Nordisk Investigational Site
Hanover, 30173
Novo Nordisk Investigational Site
Osnabrück, 49082
About this study
Official title: Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin aspart, human insulin, isophane human insulin
- 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 s.c. (under the skin) three times a day
human insulinDrug
Injected s.c. (under the skin) 30 minutes before the meals
isophane human insulinDrug
May be administered s.c. (under the skin) in both treatment groups thrice daily
| Study group | Role | What they receive |
|---|---|---|
| IAsp | Experimental | Not described Receives: Drug: insulin aspart; Drug: isophane human insulin |
| HI | Active comparator | Not described Receives: Drug: human insulin; Drug: isophane human insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoglycaemic episodes during the treatment
Measured: Week 0; week 24
Change in HbA1c (glycosylated haemoglobin A1c)
Measured: Week 0; week 24
Secondary outcomes (1)
Incidence of Adverse Events (AEs)
Measured: Week 0; week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study start19 Jun 2002
- Primary completion15 Oct 2003
- Study completion15 Oct 2003
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT01467141
- Sponsor's protocol ID
- ANA-1415
- Status last verified
- Feb 2017
- First submitted
- 4 Nov 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Danne T, Rastam J, Odendahl R, Nake A, Schimmel U, Szczepanski R, Moeller J, Deiss D. Parental preference of prandial insulin aspart compared with preprandial human insulin in a basal-bolus scheme with NPH insulin in a 12-wk crossover study of preschool children with type 1 diabetes. Pediatr Diabetes. 2007 Oct;8(5):278-85. doi: 10.1111/j.1399-5448.2007.00261.x.
PubMed 17850471
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
- Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial
- ClinicalTrials.gov ID
- NCT01467141
- Acronym / sponsor ID
- ANA-1415
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2002 (actual)
- Primary completion
- 15 Oct 2003 (actual)
- Study completion
- 15 Oct 2003 (actual)
- First posted
- 8 Nov 2011 (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 safety and efficacy in children with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IAsp | Experimental | Drug: insulin aspart, Drug: isophane human insulin |
| HI | Active comparator | Drug: human insulin, Drug: isophane human insulin |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Type 1 diabetes
- Treatment with insulin for at least 6 months prior to inclusion
- HbA1c below or equal to 11.0 %
- Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion
Key exclusion criteria (5 listed)
- The receipt of any investigational drug within one month prior to this trial
- Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
- Total daily insulin doses at least 1.80 IU/kg
- Treatment with oral hypoglycaemic agents
- Known or suspected allergy to trial product or related products
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 s.c. (under the skin) three times a day | Drug | IAsp |
| human insulinInjected s.c. (under the skin) 30 minutes before the meals | Drug | HI |
| isophane human insulinMay be administered s.c. (under the skin) in both treatment groups thrice daily | Drug | HI, IAsp |
Primary outcome
Incidence of hypoglycaemic episodes during the treatment
Time frame: Week 0; week 24
Change in HbA1c (glycosylated haemoglobin A1c)
Time frame: Week 0; week 24
1 secondary outcome
Incidence of Adverse Events (AEs)
Time frame: Week 0; week 24
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 publication: PubMed 17850471Danne T, Rastam J, Odendahl R, Nake A, Schimmel U, Szczepanski R, Moeller J, Deiss D. Parental preference of prandial insulin aspart compared with preprandial human insulin in a basal-bolus scheme with NPH insulin in a 12-wk crossover study of preschool children with type 1 diabetes. Pediatr Diabetes. 2007 Oct;8(5):278-85. doi: 10.1111/j.1399-5448.2007.00261.x.
- 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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin aspart, human insulin and isophane human insulin in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 6 sites in Germany.
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 4 inclusion and 5 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 6 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of hypoglycaemic episodes during the treatment (time frame: Week 0; week 24). The study lists 2 primary outcomes in all. 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 NCT01467141, 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.