DiabetesPhase 3NCT00604396
Safety and Efficacy of Insulin Detemir in Combination With OAD in 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 62 sites in 10 countries.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy 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 2
- What is being tested?
- insulin detemir and insulin NPH
- How many people
- 477 participants
- Where
- 62 sitesin 10 countries
- Study dates
- Mar 2003to Jan 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 at least 12 months since diagnosis
- Insulin naive subjects
- OAD treatment for at least 4 months alone or combined with no more than two OADs
- Body mass index (BMI) below 35.0 kg/m2
- HbA1c between 7.5-10.0%
- Able and willing to use twice a day injections for the entire trial period
Who cannot join
- Current or previous treatment with thiazolidiones within the last 6 months
- OAD treatment with three or more OADs within the last 6 months
- Acute insulin treatment for longer than 7 days in a row within the last 6 months
- Secondary diabetes
- Known maturity onset of diabetes of young (MODY)
- Known or suspected allergy to trial product or related products
Trial locations and contacts
62 sites in 10 countries.
62 sites in 10 countries
Poland12 sites
Novo Nordisk Investigational Site
Gniewkowo, 88-140
Novo Nordisk Investigational Site
Krakow, 31-261
Novo Nordisk Investigational Site
Lodz, 90-030
Novo Nordisk Investigational Site
Lublin, 20-718
Novo Nordisk Investigational Site
Rawa Mazowiecka, 96-200
Novo Nordisk Investigational Site
Szczecin, 71-455
Novo Nordisk Investigational Site
Tychy, 43-100
Novo Nordisk Investigational Site
Warsaw, 01-809
Novo Nordisk Investigational Site
Warsaw, 01-877
Novo Nordisk Investigational Site
Warsaw, 02-097
Novo Nordisk Investigational Site
Wołomin, 05-200
Novo Nordisk Investigational Site
Zabrze, 41-800
France11 sites
Novo Nordisk Investigational Site
Amiens
Novo Nordisk Investigational Site
Auxerre, 89000
Novo Nordisk Investigational Site
Avignon, 84902
Novo Nordisk Investigational Site
Dax, 40107
Novo Nordisk Investigational Site
Évry, 91014
Novo Nordisk Investigational Site
Mougins, 06250
Novo Nordisk Investigational Site
Nanterre, 92014
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Rueil-Malmaison, 92501
Novo Nordisk Investigational Site
Valenciennes, 59322
Novo Nordisk Investigational Site
Vénissieux, 69200
Norway9 sites
Novo Nordisk Investigational Site
Bekkestua, 1357
Novo Nordisk Investigational Site
Bergen, NO-5012
Novo Nordisk Investigational Site
Elverum, 2408
Novo Nordisk Investigational Site
Gjettum, 1346
Novo Nordisk Investigational Site
Gjøvik, NO-2819
Novo Nordisk Investigational Site
Jessheim, 2050
Novo Nordisk Investigational Site
Oslo, 0370
Novo Nordisk Investigational Site
Rådal, 5235
Novo Nordisk Investigational Site
Stavanger, 4011
Denmark8 sites
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Copenhagen, 2400
Novo Nordisk Investigational Site
Hjørring, 9800
Novo Nordisk Investigational Site
Hvidovre, 2650
Novo Nordisk Investigational Site
Kalundborg, 4400
Novo Nordisk Investigational Site
København S, 2300
Novo Nordisk Investigational Site
Køge, 4600
Novo Nordisk Investigational Site
Slagelse, 4200
Sweden8 sites
Novo Nordisk Investigational Site
Falun, 791 82
Novo Nordisk Investigational Site
Grästorp, 467 22
Novo Nordisk Investigational Site
Kristianstad, 291 85
Novo Nordisk Investigational Site
Linköping, 581 85
Novo Nordisk Investigational Site
Lund, 221 85
Novo Nordisk Investigational Site
Lund, 223 70
Novo Nordisk Investigational Site
Trelleborg, 231 85
Novo Nordisk Investigational Site
Umeå, 901 85
Russia6 sites
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 119435
Novo Nordisk Investigational Site
Moscow, 123448
Novo Nordisk Investigational Site
Moscow, 127411
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Novo Nordisk Investigational Site
Saint Petersburg, 198013
Belgium4 sites
Novo Nordisk Investigational Site
Arlon, 6700
Novo Nordisk Investigational Site
Gilly, 6060
Novo Nordisk Investigational Site
Huy, 4500
Novo Nordisk Investigational Site
Jumet, 6040
Croatia2 sites
Novo Nordisk Investigational Site
Rijeka, 51 000
Novo Nordisk Investigational Site
Zagreb, 10 000
About this study
Official title: Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus
This trial is conducted in Europe.
The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.
- 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 26 weeks of treatment
Secondary outcomes (6)
Fasting plasma glucose
Within-subject variation
Incidence of total hypoglycaemic episodes
Body weight
Incidence of adverse events
Insulin antibodies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startMar 2003
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 477 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
- NCT00604396
- Sponsor's protocol ID
- NN304-1530
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2008
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006 Jun;29(6):1269-74. doi: 10.2337/dc05-1365.
PubMed 16732007Davies MJ, Derezinski T, Pedersen CB, Clauson P. Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia. Diabetes Technol Ther. 2008 Aug;10(4):273-7. doi: 10.1089/dia.2008.0282.
PubMed 18715200Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
PubMed 33166419
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
- Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus
- ClinicalTrials.gov ID
- NCT00604396
- Acronym / sponsor ID
- NN304-1530
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 30 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 investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy 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 (6 listed)
- Type 2 diabetes for at least 12 months since diagnosis
- Insulin naive subjects
- OAD treatment for at least 4 months alone or combined with no more than two OADs
- Body mass index (BMI) below 35.0 kg/m2
- HbA1c between 7.5-10.0%
Key exclusion criteria (6 listed)
- Current or previous treatment with thiazolidiones within the last 6 months
- OAD treatment with three or more OADs within the last 6 months
- Acute insulin treatment for longer than 7 days in a row within the last 6 months
- Secondary diabetes
- Known maturity onset of diabetes of young (MODY)
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 26 weeks of treatment
6 secondary outcomes
Fasting plasma glucose
Within-subject variation
Incidence of total hypoglycaemic episodes
Body weight
Incidence of adverse events
Insulin antibodies
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 16732007Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006 Jun;29(6):1269-74. doi: 10.2337/dc05-1365.
- Results publication: PubMed 18715200Davies MJ, Derezinski T, Pedersen CB, Clauson P. Reduced weight gain with insulin detemir compared to NPH insulin is not explained by a reduction in hypoglycemia. Diabetes Technol Ther. 2008 Aug;10(4):273-7. doi: 10.1089/dia.2008.0282.
- Derived from this study: PubMed 33166419Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
- 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
62 sites in 10 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 62 sites in 10 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 6 inclusion and 6 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 62 sites in Poland, France, Norway, Denmark, Sweden and 5 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 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 NCT00604396, which also lists 3 linked publications.
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.