DiabetesPhase 3NCT00383877
Effect of Insulin Detemir on Blood Glucose Control in Subjects 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 1 site in China.
Trial summary
This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s). 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
- 263 participants
- Where
- 1 siteChina
- Study dates
- Sep 2006to Aug 2007
- 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
- HbA1C greater than 7.5% and less than or equal to 11.0%
- Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months
Who cannot join
- Previous acute treatment with insulin for more than 7 days.
- Treatment with OAD(s) which does not adhere to the approval labeling.
- Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).
- 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 of treatment
Secondary outcomes (4)
FBG
Measured: after 20 weeks of treatment
Safety profile
Measured: during 20 weeks treatment
Proportion of subjects achieving HbA1c less than or equal to 7.0%
Measured: after 20 weeks of treatment
Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial
Measured: before breakfast during the trial at the end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 263 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
- NCT00383877
- Sponsor's protocol ID
- NN304-1684
- Status last verified
- Dec 2023
- First submitted
- 3 Oct 2006
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00383877
- Acronym / sponsor ID
- NN304-1684
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 4 Oct 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 China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).
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 (3 listed)
- Type 2 diabetes
- HbA1C greater than 7.5% and less than or equal to 11.0%
- Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months
Key exclusion criteria (4 listed)
- Previous acute treatment with insulin for more than 7 days.
- Treatment with OAD(s) which does not adhere to the approval labeling.
- Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by 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 NPH | Drug | – |
Primary outcome
HbA1c
Time frame: after 20 weeks of treatment
4 secondary outcomes
FBG
Time frame: after 20 weeks of treatment
Safety profile
Time frame: during 20 weeks treatment
Proportion of subjects achieving HbA1c less than or equal to 7.0%
Time frame: after 20 weeks of treatment
Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial
Time frame: before breakfast during the trial at the end of the trial
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 2 Jan 2024.
- 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 China.
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 3 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 2 Jan 2024. 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 China. 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 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2024.