DiabetesPhase 3NCT00604253
Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone
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 1 site in Japan.
Trial summary
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment. Read more about this study
- Who is it for?
- Ages 20 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
- 362 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2003to May 2005
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duration of type 2 diabetes mellitus for at least one year
- Insulin naive patients
- OHA treatment for at least 12 weeks
- HbA1C between 7.5-10.0%
- Body Mass Index (BMI) below 30.0 kg/m2
Who cannot join
- Impaired renal function
- Impaired hepatic function
- Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy and the Safety of Insulin Detemir and Insulin NPH as add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.
- 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 36 weeks of treatment
Secondary outcomes (4)
Plasma glucose profiles
Incidence of hypoglycaemic episodes
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 startDec 2003
- Primary completionMay 2005
- Study completionMay 2005
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
- 362 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
- NCT00604253
- Sponsor's protocol ID
- NN304-1477
- Other IDs
- JapicCTI-R070009
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2008
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 36-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Once Daily Treatment as an Add-on Current Oral Hypoglycemic Agents. J. Japan Diab. Soc 2007; 50 (9): 665-677
Tajima N, Iwamoto Y, Kaku K, Kawamori R, Nishida T, Kobayashi M. Once-daily insulin detemir added to oral antidiabetic drugs results in less weight gain and a trend for reduced hypoglycaemia in comparison with NPH insulin in Japanese patients with type 2 diabetes. Diabetologia 2006; 49 (Suppl. 1): 609 (Abstract 996)
Semlitsch 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
- Comparison of Efficacy and the Safety of Insulin Detemir and Insulin NPH as add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00604253
- Acronym / sponsor ID
- NN304-1477
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (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 Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in type 2 diabetes when added to current OHA treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Duration of type 2 diabetes mellitus for at least one year
- Insulin naive patients
- OHA treatment for at least 12 weeks
- HbA1C between 7.5-10.0%
- Body Mass Index (BMI) below 30.0 kg/m2
Key exclusion criteria (3 listed)
- Impaired renal function
- Impaired hepatic function
- Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods
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 36 weeks of treatment
4 secondary outcomes
Plasma glucose profiles
Incidence of hypoglycaemic episodes
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 publicationKobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 36-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Once Daily Treatment as an Add-on Current Oral Hypoglycemic Agents. J. Japan Diab. Soc 2007; 50 (9): 665-677
- Results publicationTajima N, Iwamoto Y, Kaku K, Kawamori R, Nishida T, Kobayashi M. Once-daily insulin detemir added to oral antidiabetic drugs results in less weight gain and a trend for reduced hypoglycaemia in comparison with NPH insulin in Japanese patients with type 2 diabetes. Diabetologia 2006; 49 (Suppl. 1): 609 (Abstract 996)
- 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
1 site 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 and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
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 1 site in Japan. 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 36 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 NCT00604253, 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.