DiabetesPhase 3NCT00283751
Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes
A Phase 3 study testing insulin detemir and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 96 sites in 7 countries.
Trial summary
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2… 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 glargine
- How many people
- 583 participants
- Where
- 96 sitesin 7 countries
- Study dates
- Mar 2003to Nov 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
- Type 2 Diabetes for more than 12 months, and no previous insulin treatment
- Oral Antidiabetic Drug treatment for at least 4 months
- Body Mass Index (BMI) less than 40 kg/m2
- HbA1c 7.5-10.0%
Who cannot join
- Current or previous treatment with thiazolidinediones within the last 6 months
- Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
- Proliferative retinopathy or maculopathy
- Known hypoglycaemia unawareness
Trial locations and contacts
96 sites in 7 countries.
96 sites in 7 countries
Germany31 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, 13355
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Flensburg, 24939
Novo Nordisk Investigational Site
Frankfurt, 60590
Novo Nordisk Investigational Site
Freiburg im Breisgau, 79106
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Fürth, 93437
Novo Nordisk Investigational Site
Genthin, 39307
Novo Nordisk Investigational Site
Giessen, 35390
Novo Nordisk Investigational Site
Hamburg, 20251
Novo Nordisk Investigational Site
Hamburg, 21073
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Heidelberg, 69115
Novo Nordisk Investigational Site
Krefeld, 47798
Novo Nordisk Investigational Site
Ludwigshafen, 67059
Novo Nordisk Investigational Site
Marl, 45770
Novo Nordisk Investigational Site
München, 81925
Novo Nordisk Investigational Site
Neumünster, 24534
Novo Nordisk Investigational Site
Neuss, 41460
Novo Nordisk Investigational Site
Nuremberg, 90402
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Saarbrücken, 66121
Novo Nordisk Investigational Site
Saint Ingbert, 66386
Novo Nordisk Investigational Site
Schaafheim, 64850
Novo Nordisk Investigational Site
Schwabenheim, 55270
Novo Nordisk Investigational Site
Schwedt, 16303
Novo Nordisk Investigational Site
Völklingen, 66333
Novo Nordisk Investigational Site
Würzburg, 97072
United States21 sites
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dallas, Texas, 75390-8858
Novo Nordisk Investigational Site
Greenbrae, California, 94904
Novo Nordisk Investigational Site
Kettering, Ohio, 45429
Novo Nordisk Investigational Site
La Mesa, California, 91942
Novo Nordisk Investigational Site
Lincoln, Nebraska, 68521
Novo Nordisk Investigational Site
Mt. Pleasant, South Carolina, 29464
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19140
Novo Nordisk Investigational Site
Pleasantville, New Jersey, 08232
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
Seattle, Washington, 98105
Novo Nordisk Investigational Site
Springfield, Illinois, 62711
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Warrenton, Virginia, 20186
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33401
United Kingdom17 sites
Novo Nordisk Investigational Site
Ayr, KA6 6DX
Novo Nordisk Investigational Site
Barnsley, S75 2EP
Novo Nordisk Investigational Site
Bolton, BL1 4QS
Novo Nordisk Investigational Site
Bradford, BD9 6RJ
Novo Nordisk Investigational Site
Church Village, CF38 1AB
Novo Nordisk Investigational Site
Cosham, PO6 3LY
Novo Nordisk Investigational Site
Dundee, DD1 9SY
Novo Nordisk Investigational Site
Glasgow, G42 9TY
Novo Nordisk Investigational Site
Harrow, HA1 3UJ
Novo Nordisk Investigational Site
Leicester, LE1 5WW
Novo Nordisk Investigational Site
Leicester, LE5 4PW
Novo Nordisk Investigational Site
Livingstone, EH54 6PP
Novo Nordisk Investigational Site
London, SE5 9RS
Novo Nordisk Investigational Site
Newcastle, NE7 7DN
Novo Nordisk Investigational Site
Poole, BH15 2JB
Novo Nordisk Investigational Site
Salford, M6 8HD
Novo Nordisk Investigational Site
Swansea, SA6 6NL
France13 sites
Novo Nordisk Investigational Site
Besançon, 25030
Novo Nordisk Investigational Site
Bondy, 93143
Novo Nordisk Investigational Site
Grenoble, 38043
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Lyon, 69437
Novo Nordisk Investigational Site
Nantes, 44093
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nîmes, 30006
Novo Nordisk Investigational Site
Paris, 75475
Novo Nordisk Investigational Site
Paris, 75877
Novo Nordisk Investigational Site
Poitiers, 86000
Novo Nordisk Investigational Site
Strasbourg, 67091
Novo Nordisk Investigational Site
Toulouse, 31054
Austria7 sites
Novo Nordisk Investigational Site
Ebreichsdorf, 2483
Novo Nordisk Investigational Site
Gratwein, 8112
Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Neunkirchen, 2620
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, A 1160
Novo Nordisk Investigational Site
Wolfsberg, 9400
Belgium5 sites
Novo Nordisk Investigational Site
Bonheiden, 2820
Novo Nordisk Investigational Site
Brussels, 1090
Novo Nordisk Investigational Site
Edegem, 2650
Novo Nordisk Investigational Site
Ghent, 9000
Novo Nordisk Investigational Site
Leuven, 3000
Ireland2 sites
Novo Nordisk Investigational Site
Dublin, DUBLIN 8
Novo Nordisk Investigational Site
Dublin
About this study
Official title: Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir, insulin glargine
- 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 glargineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: after 52 weeks
Secondary outcomes (4)
Insulin antibodies
Incident of hypoglycaemic episodes and adverse events
Plasma glucose profiles
Change in body weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startMar 2003
- Primary completionNov 2004
- Study completionNov 2004
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
- 583 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
- NCT00283751
- Sponsor's protocol ID
- NN304-1373
- Status last verified
- Jan 2017
- First submitted
- 27 Jan 2006
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.
PubMed 18204830
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 as Add-on to Current Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00283751
- Acronym / sponsor ID
- NN304-1373
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 30 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 and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients 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 12 months, and no previous insulin treatment
- Oral Antidiabetic Drug treatment for at least 4 months
- Body Mass Index (BMI) less than 40 kg/m2
- HbA1c 7.5-10.0%
Key exclusion criteria (4 listed)
- Current or previous treatment with thiazolidinediones within the last 6 months
- Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
- Proliferative retinopathy or maculopathy
- Known hypoglycaemia unawareness
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 | – |
Primary outcome
HbA1c
Time frame: after 52 weeks
4 secondary outcomes
Insulin antibodies
Incident of hypoglycaemic episodes and adverse events
Plasma glucose profiles
Change in body weight
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 18204830Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.
- 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
96 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin detemir and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 96 sites in 7 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 4 inclusion and 4 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 96 sites in Germany, United States, United Kingdom, France, Austria and 2 more countries. 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 52 weeks). 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 NCT00283751, 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.