DiabetesPhase 3NCT00595374
Efficacy and Safety of Insulin Detemir in Type 1 Diabetes
A Phase 3 study testing insulin detemir, insulin NPH and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 18 sites in Netherlands.
Trial summary
This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control. 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 detemir, insulin NPH and insulin aspart
- How many people
- 114 participants
- Where
- 18 sitesNetherlands
- Study dates
- 2 Dec 2003to 7 Oct 2004
- 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
- Duration of type 1 diabetes for at least 12 months
- BMI below 35 kg/m2
- HbA1c between 7.0-12.0%
- Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
- Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator
Who cannot join
- Known or suspected allergy to trial product or related products
- Previous participation in this trial
- Receipt of any investigational products within the last 2 months prior to this trial
- Drug or alcohol dependence
- Pregnancy, breast-feeding or intention of becoming pregnant
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Netherlands18 sites
Novo Nordisk Investigational Site
Amersfoort, 3818 ES
Novo Nordisk Investigational Site
Apeldoorn, 7334 DZ
Novo Nordisk Investigational Site
Den Helder, 1782 GZ
Novo Nordisk Investigational Site
Deventer, 7415 CM
Novo Nordisk Investigational Site
Enschede, 7511 JX
Novo Nordisk Investigational Site
Gouda, 2805 AH
Novo Nordisk Investigational Site
Hoogeveen, 7909 AA
Novo Nordisk Investigational Site
Leidschendam, 2262 BA
Novo Nordisk Investigational Site
Meppel, 7943 KA
Novo Nordisk Investigational Site
Rotterdam, 3083 AN
Novo Nordisk Investigational Site
Stadskanaal, 9501 EH
Novo Nordisk Investigational Site
The Hague, 2566 MJ
Novo Nordisk Investigational Site
The Hague, 2597 AX
Novo Nordisk Investigational Site
Utrecht, 3563 AZ
Novo Nordisk Investigational Site
Waalwijk, 5141 BM
Novo Nordisk Investigational Site
Weert, 6001 BE
Novo Nordisk Investigational Site
Zevenaar, 6903 ZN
Novo Nordisk Investigational Site
Zwolle, 8025 AB
About this study
Official title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus
This trial is conducted in Europe.
The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin detemir, insulin NPH, insulin aspart
- 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 detemirDrug
insulin NPHDrug
insulin aspartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 26 weeks of treatment
Secondary outcomes (5)
Plasma glucose profiles
Change in body weight
Quality of Life
Incidence of adverse events
Incidence of hypoglycaemic episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study start2 Dec 2003
- Primary completion7 Oct 2004
- Study completion7 Oct 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 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
- NCT00595374
- Sponsor's protocol ID
- NN304-1582
- Status last verified
- Feb 2017
- First submitted
- 7 Jan 2008
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00595374
- Acronym / sponsor ID
- NN304-1582
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2003 (actual)
- Primary completion
- 7 Oct 2004 (actual)
- Study completion
- 7 Oct 2004 (actual)
- First posted
- 16 Jan 2008 (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 compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.
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 (5 listed)
- Duration of type 1 diabetes for at least 12 months
- BMI below 35 kg/m2
- HbA1c between 7.0-12.0%
- Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
- Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator
Key exclusion criteria (5 listed)
- Known or suspected allergy to trial product or related products
- Previous participation in this trial
- Receipt of any investigational products within the last 2 months prior to this trial
- Drug or alcohol dependence
- Pregnancy, breast-feeding or intention of becoming pregnant
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 NPH | Drug | – |
| insulin aspart | Drug | – |
Primary outcome
HbA1c
Time frame: after 26 weeks of treatment
5 secondary outcomes
Plasma glucose profiles
Change in body weight
Quality of Life
Incidence of adverse events
Incidence of hypoglycaemic episodes
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 24 Feb 2017.
- 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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin detemir, insulin NPH and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 18 sites in Netherlands.
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 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 24 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 18 sites in Netherlands. 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?
HbA1c (time frame: after 26 weeks of treatment). 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 24 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.