DiabetesPhase 3NCT00104182
Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes
A Phase 3 study testing insulin detemir and insulin NPH 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 this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients 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 NPH
- How many people
- 503 participants
- Where
- 96 sitesin 7 countries
- Study dates
- Feb 2005to Feb 2006
- 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 at least 12 months
- Currently treated with Oral Antidiabetic Drugs
- BMI lesser than or equal to 40 kg/m2
- HbA1c greater than or equal 7.5 and lesser than or equal to 11%
Who cannot join
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
Trial locations and contacts
96 sites in 7 countries.
96 sites in 7 countries
United States29 sites
Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Birmingham, Alabama, 35235
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45291
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Connellsville, Pennsylvania, 15425
Novo Nordisk Investigational Site
Conroe, Texas, 77384
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
Novo Nordisk Investigational Site
Denver, Colorado, 80220
Novo Nordisk Investigational Site
Fall River, Massachusetts, 02721
Novo Nordisk Investigational Site
Fullerton, California, 92835
Novo Nordisk Investigational Site
Grand Forks, North Dakota, 58201
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Killeen, Texas, 76543
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Lake Mary, Florida, 32746
Novo Nordisk Investigational Site
Lancaster, Pennsylvania, 17601
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89030
Novo Nordisk Investigational Site
Lewiston, New York, 14092
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Mesa, Arizona, 85205
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Orange, California, 92869
Novo Nordisk Investigational Site
Phoenix, Arizona, 85029
Novo Nordisk Investigational Site
Poway, California, 92064
Novo Nordisk Investigational Site
Seattle, Washington, 98105
Novo Nordisk Investigational Site
Springfield, Illinois, 62711
Novo Nordisk Investigational Site
Waltham, Massachusetts, 02453
Novo Nordisk Investigational Site
Williamsville, New York, 14221
Spain17 sites
Novo Nordisk Investigational Site
Alcorcón, 28922
Novo Nordisk Investigational Site
Almería, 04009
Novo Nordisk Investigational Site
Barcelona, 08017
Novo Nordisk Investigational Site
Barcelona, 08025
Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Bilbao, 48013
Novo Nordisk Investigational Site
Cadiz, 11009
Novo Nordisk Investigational Site
Getafe, 28905
Novo Nordisk Investigational Site
Gijón, 33206
Novo Nordisk Investigational Site
Granada, 18012
Novo Nordisk Investigational Site
Palma de Mallorca, 07198
Novo Nordisk Investigational Site
Pamplona, 31008
Novo Nordisk Investigational Site
Santa Cruz de Tenerife, 38010
Novo Nordisk Investigational Site
Santiago de Compostela, 15706
Novo Nordisk Investigational Site
Valencia, 46026
Novo Nordisk Investigational Site
Valladolid, 47010
Novo Nordisk Investigational Site
Valladolid, 47011
Denmark12 sites
Novo Nordisk Investigational Site
Aalborg, 9000
Novo Nordisk Investigational Site
Copenhagen, 2400
Novo Nordisk Investigational Site
Esbjerg, 6700
Novo Nordisk Investigational Site
Glostrup Municipality, 2600
Novo Nordisk Investigational Site
Herlev, 2730
Novo Nordisk Investigational Site
Hillerød, 3400
Novo Nordisk Investigational Site
Hjørring, 9800
Novo Nordisk Investigational Site
Horsens, 8700
Novo Nordisk Investigational Site
Hvidovre, 2650
Novo Nordisk Investigational Site
København S, 2300
Novo Nordisk Investigational Site
Næstved, 4700
Novo Nordisk Investigational Site
Roskilde, 4000
Italy12 sites
Novo Nordisk Investigational Site
Cagliari, 09134
Novo Nordisk Investigational Site
Catania, 95126
Novo Nordisk Investigational Site
Genova, 16132
Novo Nordisk Investigational Site
Messina, 98123
Novo Nordisk Investigational Site
Monza, 20052
Novo Nordisk Investigational Site
Naples, 80131
Novo Nordisk Investigational Site
Parma, 43100
Novo Nordisk Investigational Site
Pescara, 65124
Novo Nordisk Investigational Site
Prato, 59100
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
Torino, 10126
Novo Nordisk Investigational Site
Treviso, 31100
France10 sites
Novo Nordisk Investigational Site
Bagnols-sur-Cèze, 30200
Novo Nordisk Investigational Site
Besançon, 25030
Novo Nordisk Investigational Site
Carcassonne, 11000
Novo Nordisk Investigational Site
Corbeil-Essonnes, 91106
Novo Nordisk Investigational Site
Dax, 40107
Novo Nordisk Investigational Site
Montpellier, 34295
Novo Nordisk Investigational Site
Quimper, 29107
Novo Nordisk Investigational Site
Rueil-Malmaison, 92501
Novo Nordisk Investigational Site
Tours, 37044
Novo Nordisk Investigational Site
Vénissieux, 69200
Norway9 sites
Novo Nordisk Investigational Site
Bergen, 5021
Novo Nordisk Investigational Site
Bergen, NO-5012
Novo Nordisk Investigational Site
Elverum, 2408
Novo Nordisk Investigational Site
Gjøvik, NO-2819
Novo Nordisk Investigational Site
Kongsvinger, 2212
Novo Nordisk Investigational Site
Oslo, 0370
Novo Nordisk Investigational Site
Oslo, 0586
Novo Nordisk Investigational Site
Stavanger, 4011
Novo Nordisk Investigational Site
Trondheim, NO-7030
Netherlands7 sites
Novo Nordisk Investigational Site
's-Hertogenbosch, 5216 GC
Novo Nordisk Investigational Site
Almelo, 7609 PP
Novo Nordisk Investigational Site
Etten-Leur, 4872 LP
Novo Nordisk Investigational Site
Roelofarendsveen, 2371 RB
Novo Nordisk Investigational Site
Rotterdam, 3082 DC
Novo Nordisk Investigational Site
The Hague, 2584 HV
Novo Nordisk Investigational Site
Vlodrop, 6063 DA
About this study
Official title: Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir, insulin NPH
- 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 NPHDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Measured: after 20 weeks
Secondary outcomes (4)
Adverse events
body weight
Hypoglycemia
Blood glucose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2006
- Study completionFeb 2006
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
- 503 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
- NCT00104182
- Sponsor's protocol ID
- NN304-1632
- Other IDs
- 2004-001461-18, 2004
- Status last verified
- Jan 2017
- First submitted
- 23 Feb 2005
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006 Oct;28(10):1569-81. doi: 10.1016/j.clinthera.2006.10.020.
PubMed 17157113
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00104182
- Acronym / sponsor ID
- NN304-1632
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 24 Feb 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.
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs 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 at least 12 months
- Currently treated with Oral Antidiabetic Drugs
- BMI lesser than or equal to 40 kg/m2
- HbA1c greater than or equal 7.5 and lesser than or equal to 11%
Key exclusion criteria (3 listed)
- Proliferative retinopathy or maculopathy
- Recurrent major hypoglycaemia
- uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial
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 | – |
Primary outcome
HbA1C
Time frame: after 20 weeks
4 secondary outcomes
Adverse events
body weight
Hypoglycemia
Blood glucose
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 30 Jan 2017.
- Results publication: PubMed 17157113Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006 Oct;28(10):1569-81. doi: 10.1016/j.clinthera.2006.10.020.
- 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 NPH 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 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 30 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 United States, Spain, Denmark, Italy, France 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 20 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 NCT00104182, 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 30 Jan 2017.