Type 1 Diabetes MellitusPhase 4NCT00145353
Insulin NovoRapid Versus Actrapid in Treatment of Type 1 Diabetic Patients During Daily Adjustment of Insulin Dose
A Phase 4 study testing Insulin NovoRapid versus Actrapid in people with Type 1 Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin Aspart at meals together with NPH insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin NovoRapid versus Actrapid
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2004to Jun 2006
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening.
- AGe: 18-60 years
- BMI: 18-27.5
- No nefro- or neuropathy; i.e. S-creatinin below 120 μmol/l and normal monofilament examination
- Written informed consent
Who cannot join
- Pregnant women or patients planning to become pregnant during the investigation period
- Reduced eyesight; i.e. visus > 0.3 evaluated at the latest eye exam.
- Patient lacking the ability to sens insulin sensitivity
- Serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.
- Suspicion of abuse or non-compliance
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?
The main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin Aspart at meals together with NPH insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and when the patients in both periods simultaneously take extra insulin at meals if high blood glucose values are found before meals.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin NovoRapid versus Actrapid
- Keywords
- type 1 diabetes mellitus, hypoglycaemia, insulin profiles, growth hormone, cortisol, glucagon
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin NovoRapid versus ActrapidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Meal-regulated insulin time two peaks after the two intervention periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startNov 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Double blind
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Iben B. Jacobsen, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145353
- Sponsor's protocol ID
- 007
- Status last verified
- Oct 2006
- First submitted
- 2 Sep 2005
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Insulin NovoRapid Better Than Actrapid for Treating Type 1 Diabetic Patients When Simultaneously, Daily Adjusting the Insulin Dose?
- ClinicalTrials.gov ID
- NCT00145353
- Acronym / sponsor ID
- 007
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes mellitus, hypoglycaemia, insulin profiles, growth hormone, cortisol, glucagon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Jun 2006
- First posted
- 5 Sep 2005 (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.
The main purpose of the study is to investigate the reason for the reduced number of hypoglycaemic attacks in type 1 diabetic patients when, for a period of time, using Insulin Aspart at meals together with NPH insulin mornings and evenings, and when, in another period of time, using human fast-working insulin at meals and NPH insulin mornings and evenings, and when the patients in both periods simultaneously take extra insulin at meals if high blood glucose values are found before meals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Type 1 diabetes mellitus treated with insulin four times daily (basal bolus treatment) at least three months before screening.
- AGe: 18-60 years
- BMI: 18-27.5
- No nefro- or neuropathy; i.e. S-creatinin below 120 μmol/l and normal monofilament examination
- Written informed consent
Key exclusion criteria (6 listed)
- Pregnant women or patients planning to become pregnant during the investigation period
- Reduced eyesight; i.e. visus > 0.3 evaluated at the latest eye exam.
- Patient lacking the ability to sens insulin sensitivity
- Serious rival disease, i.e. heart disease, severe liver or lung impairment, severe psychiatric disease.
- Suspicion of abuse or non-compliance
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 NovoRapid versus Actrapid | Drug | – |
Primary outcome
Meal-regulated insulin time two peaks after the two intervention periods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
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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.
Iben B. Jacobsen, MD principal investigator
Odense University Hospital
1 site 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 NovoRapid versus Actrapid in people with Type 1 Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
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?
Meal-regulated insulin time two peaks after the two intervention periods. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2006.