DiabetesPhase 4NCT00455858

Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

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 South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea. 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteSouth Korea
Study dates: Nov 2007to Oct 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 (diagnosed more than 12 months ago)
HbA1c greater than 7.0 and less than 12.0% at screening
Currently on any OAD in more than 3 months ago
BMI (Body Mass Index) less than 35kg/m2

Who cannot join

Previous treatment with insulin in more than 7 days within the last 3 months
Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Study site
Seoul

Other trials in South Korea

About this study

Official title: A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy in Korea

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
Also called Levemir®
Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).

Study groups in NCT00455858
Study group	Role	What they receive
insulin detemir	Active comparator	Not described Receives: Drug: insulin detemir

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20
Measured: week 0, week 20

Secondary outcomes (4)

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12
Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline
Measured: week 0, week 12
Change in Fasting Plasma Glucose (FPG)
Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20
Measured: week 0, week 12, week 20
Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%
Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%
Measured: week 12, week 20
Occurence of Hypoglycaemic Episodes
Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.
Measured: weeks 0-20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Oct 2008

First posted4 Apr 2007 (estimated)
Study startNov 2007
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00455858
Sponsor's protocol ID: NN304-1762
Status last verified: Jan 2024
First submitted: 3 Apr 2007
Last updated: 1 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy in Korea
ClinicalTrials.gov ID: NCT00455858
Acronym / sponsor ID: NN304-1762
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 4 Apr 2007 (estimated)
Results: Posted 23 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
insulin detemir	Active comparator	Drug: insulin detemir

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 (diagnosed more than 12 months ago)
HbA1c greater than 7.0 and less than 12.0% at screening
Currently on any OAD in more than 3 months ago
BMI (Body Mass Index) less than 35kg/m2

Key exclusion criteria (2 listed)

Previous treatment with insulin in more than 7 days within the last 3 months
Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)

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 detemirAlso: Levemir®Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).	Drug	insulin detemir

Primary outcome

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
Time frame: week 0, week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20

4 secondary outcomes

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12
Time frame: week 0, week 12
Change in Fasting Plasma Glucose (FPG)
Time frame: week 0, week 12, week 20
Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%
Time frame: week 12, week 20
Occurence of Hypoglycaemic Episodes
Time frame: weeks 0-20

Results and safety

Results posted to the registry on 23 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Detemir	87	81

Primary outcome: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20

Time frame: week 0, week 20. Mean (Standard Deviation). Unit: percentage change in HbA1c

Measure	Insulin Detemir n = 81
HbA1c at baseline	9.3 (1.1)
HbA1c at week 20	8.2 (1.1)
Change in HbA1c from baseline to week 20	-1.2 (0.9)

Insulin Detemir: Least Square Mean: -1.356 (95% CI -1.368 to -1.344), p <.0001, t-test

Population analysed: The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected in a time span of 22 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Detemir	5 of 87 (5.7%)	15 of 87 (17.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 South Korea.

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 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 1 Feb 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 South Korea. 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?

Yes. Results are posted in the registry (first posted 23 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 (time frame: week 0, week 20). 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 NCT00455858.

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 1 Feb 2024.