DiabetesPhase 3NCT00312104
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes
A Phase 3 study testing insulin detemir, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 46 sites in 3 countries.
Trial summary
The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes. 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 glargine and insulin aspart
- How many people
- 325 participants
- Where
- 46 sitesin 3 countries
- Study dates
- Apr 2002to Mar 2003
- 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
- Type 1 diabetes for at least 12 months
- Current daily insulin dose of more than 1.4 IU/kg
- BMI lesser than or equal to 35 kg/m2
- HbA1c greater than 7.5% and less than or equal to 12.0%
- In Austria, age more than 19 years
Who cannot join
- Proliferate retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator
Trial locations and contacts
46 sites in 3 countries.
46 sites in 3 countries
Germany37 sites
Novo Nordisk Investigational Site
Bad Kreuznach, 55545
Novo Nordisk Investigational Site
Bad Mergentheim, 97980
Novo Nordisk Investigational Site
Bad Neuenahr-Ahrweiler, 53474
Novo Nordisk Investigational Site
Berlin, 10789
Novo Nordisk Investigational Site
Diez, 65582
Novo Nordisk Investigational Site
Erlangen, 91052
Novo Nordisk Investigational Site
Essen, 45138
Novo Nordisk Investigational Site
Flensburg, 24939
Novo Nordisk Investigational Site
Frankfurt, 60590
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Genthin, 39307
Novo Nordisk Investigational Site
Halle, 06120
Novo Nordisk Investigational Site
Hamburg, 20251
Novo Nordisk Investigational Site
Hanover, 30171
Novo Nordisk Investigational Site
Heidelberg, 69115
Novo Nordisk Investigational Site
Hennigsdorf, 16761
Novo Nordisk Investigational Site
Hünxe, 46569
Novo Nordisk Investigational Site
Jena, 07743
Novo Nordisk Investigational Site
Kiel, 24105
Novo Nordisk Investigational Site
Landau, 76829
Novo Nordisk Investigational Site
Ludwigshafen, 67059
Novo Nordisk Investigational Site
Marl, 45770
Novo Nordisk Investigational Site
Mönchengladbach, 41061
Novo Nordisk Investigational Site
Neunkirchen, 66538
Novo Nordisk Investigational Site
Neuss, 41460
Novo Nordisk Investigational Site
Northeim, 37154
Novo Nordisk Investigational Site
Nuremberg, 90402
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Rheda-Wiedenbrück, 33378
Novo Nordisk Investigational Site
Saarbrücken, 66121
Novo Nordisk Investigational Site
Saarlouis, 66740
Novo Nordisk Investigational Site
Schönebeck, 39218
Novo Nordisk Investigational Site
Schwabenheim, 55270
Novo Nordisk Investigational Site
Schwerin, 19049
Novo Nordisk Investigational Site
Völklingen, 66333
Novo Nordisk Investigational Site
Wiesbaden, 65183
Novo Nordisk Investigational Site
Würzburg, 97072
Austria5 sites
Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, 1090
Novo Nordisk Investigational Site
Vienna, A 1160
Novo Nordisk Investigational Site
Vienna, A-1130
South Africa4 sites
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7130
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7925
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4091
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2193
About this study
Official title: Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.
The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin detemir, insulin glargine, 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 glargineDrug
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 (4)
Adverse events
Body weight
Blood glucose
Hypoglycaemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startApr 2002
- Primary completionMar 2003
- Study completionMar 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 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
- NCT00312104
- Sponsor's protocol ID
- NN304-1372
- Status last verified
- Jan 2017
- First submitted
- 5 Apr 2006
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pieber TR, Treichel HC, Hompesch B, Philotheou A, Mordhorst L, Gall MA, Robertson LI. Comparison of insulin detemir and insulin glargine in subjects with Type 1 diabetes using intensive insulin therapy. Diabet Med. 2007 Jun;24(6):635-42. doi: 10.1111/j.1464-5491.2007.02113.x. Epub 2007 Mar 22.
PubMed 17381500
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT00312104
- Acronym / sponsor ID
- NN304-1372
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 7 Apr 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.
The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 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 (5 listed)
- Type 1 diabetes for at least 12 months
- Current daily insulin dose of more than 1.4 IU/kg
- BMI lesser than or equal to 35 kg/m2
- HbA1c greater than 7.5% and less than or equal to 12.0%
- In Austria, age more than 19 years
Key exclusion criteria (3 listed)
- Proliferate retinopathy or maculopathy
- Recurrent major hypoglycaemia
- Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator
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 glargine | Drug | – |
| insulin aspart | Drug | – |
Primary outcome
HbA1c
Time frame: after 26 weeks of treatment
4 secondary outcomes
Adverse events
Body weight
Blood glucose
Hypoglycaemia
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 27 Jan 2017.
- Results publication: PubMed 17381500Pieber TR, Treichel HC, Hompesch B, Philotheou A, Mordhorst L, Gall MA, Robertson LI. Comparison of insulin detemir and insulin glargine in subjects with Type 1 diabetes using intensive insulin therapy. Diabet Med. 2007 Jun;24(6):635-42. doi: 10.1111/j.1464-5491.2007.02113.x. Epub 2007 Mar 22.
- 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
46 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin detemir, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 46 sites in 3 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 5 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 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Germany, Austria, South Africa. 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?
On the ClinicalTrials.gov record for NCT00312104, 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 27 Jan 2017.