DiabetesPhase 4NCT00274274
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes
A Phase 4 study testing insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir and insulin aspart
- How many people
- 373 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2005to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes for more than 6 months
- Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
- Body Mass Index (BMI) less than or equal to 40 kg/m2
- HbA1c 7.0-11.0%
Who cannot join
- Treatment with short acting insulin(s) for longer than 10 days
- Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
- Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes
This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin detemirDrug
insulin aspartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 52 weeks
Secondary outcomes (6)
Blood glucose profiles
Percentage of patients with HbA1c less than 7.0% after 52 weeks
Quality of Life
Frequency of BG measurements
Safety parameters
Duration of education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startSep 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 373 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
- NCT00274274
- Sponsor's protocol ID
- NN304-1657
- Other IDs
- 2005-000319-87, 2005
- Status last verified
- Nov 2014
- First submitted
- 9 Jan 2006
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Insulin Aspart in a Fixed or Flexible Supplementary Insulin Therapy Regimen, With or Without Insulin Detemir in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00274274
- Acronym / sponsor ID
- NN304-1657
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 10 Jan 2006 (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. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insulin Detemir plus Metformin, if needed, in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 Diabetes for more than 6 months
- Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
- Body Mass Index (BMI) less than or equal to 40 kg/m2
- HbA1c 7.0-11.0%
Key exclusion criteria (3 listed)
- Treatment with short acting insulin(s) for longer than 10 days
- Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
- Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months
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 detemir | Drug | – |
| insulin aspart | Drug | – |
Primary outcome
HbA1c
Time frame: after 52 weeks
6 secondary outcomes
Blood glucose profiles
Percentage of patients with HbA1c less than 7.0% after 52 weeks
Quality of Life
Frequency of BG measurements
Safety parameters
Duration of education
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 21 Nov 2014.
- 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
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 detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site 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 3 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 21 Nov 2014. 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 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?
HbA1c (time frame: after 52 weeks). 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 21 Nov 2014.