DiabetesPhase 4NCT00521690
The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OAD
A Phase 4 study testing insulin detemir in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Taiwan.
Trial summary
The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin detemir
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2006to Aug 2007
- Phase
- Phase 4
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- HbA1C: 7.0-11.0%
- Previous diabetes treatment for at least 6 months
- BMI max. 35 kg/m2
- Treatment with an oral anti-diabetic drug (OAD)
Who cannot join
- Type 1 diabetes
- Receipt of any investigational drug within the last three months prior to this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment
The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin detemir
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events, including major hypoglycaemic events
Measured: during 16 weeks of insulin detemir therapy
Secondary outcomes (4)
Change in HbA1C
Measured: after 16 weeks
Change in weight
Change in fasting plasma glucose (FPG)
Incidence of hypoglycaemic episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startDec 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT00521690
- Sponsor's protocol ID
- NN304-1764
- Status last verified
- Oct 2023
- First submitted
- 27 Aug 2007
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment
- ClinicalTrials.gov ID
- NCT00521690
- Acronym / sponsor ID
- NN304-1764
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 28 Aug 2007 (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.
The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes
- HbA1C: 7.0-11.0%
- Previous diabetes treatment for at least 6 months
- BMI max. 35 kg/m2
- Treatment with an oral anti-diabetic drug (OAD)
Key exclusion criteria (2 listed)
- Type 1 diabetes
- Receipt of any investigational drug within the last three months prior to this 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 | – |
Primary outcome
Incidence of serious adverse events, including major hypoglycaemic events
Time frame: during 16 weeks of insulin detemir therapy
4 secondary outcomes
Change in HbA1C
Time frame: after 16 weeks
Change in weight
Change in fasting plasma glucose (FPG)
Incidence of hypoglycaemic episodes
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 Nov 2023.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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 4 study testing insulin detemir in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Taiwan.
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 2 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 Nov 2023. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of serious adverse events, including major hypoglycaemic events (time frame: during 16 weeks of insulin detemir therapy). 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 Nov 2023.