DiabetesNCT01821846
Investigating the Safety Profile of Liraglutide Under Normal Conditions of Use in Korean Subjects With Type 2 Diabetes Mellitus
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 7 sites in South Korea.
Trial summary
This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide
- Type of treatment
- Injection or infusion
- How many people
- 64 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 20 Nov 2013to 8 Mar 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Victoza® will be prescribed and titrated by the physician.
Who may be able to join
- Subjects with T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician
- Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information
Who cannot join
- Subjects with a hypersensitivity to Victoza® or to any of the excipients
- Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
- Subjects with personal or family history of medullary thyroid carcinoma (MTC)
- Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Novo Nordisk Investigational Site
Pyungchon-Dong 896, Dongan-Gu, 431-796
Novo Nordisk Investigational Site
Seoul, 02447
Novo Nordisk Investigational Site
Seoul, 03080
Novo Nordisk Investigational Site
Seoul, 150-950
Novo Nordisk Investigational Site
Ulsan, 44455
Novo Nordisk Investigational Site
Ulsan, 682-060
Novo Nordisk Investigational Site
Wŏnju, 220-701
About this study
Official title: A 6-month, Multi-centre, Open Labelled, Non-randomized, Non-interventional, Safety Study of Liraglutide (Victoza®) in Subjects With Type 2 Diabetes Mellitus in Korea
This trial is conducted in Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide
- 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.
liraglutideDrug
Administered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm).
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Not described Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of SADRs (Serious Adverse Drug Reactions)
Measured: Up to 6 months
Secondary outcomes (4)
HbA1c (Glycosylated haemoglobin) change
Measured: Month 0, month 6
Percentage of subjects reaching the target of HbA1c below 7.0%
Measured: Month 6
Change in body weight
Measured: Month 0, month 6
Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study start20 Nov 2013
- Primary completion8 Mar 2017
- Study completion8 Mar 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 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
- NCT01821846
- Sponsor's protocol ID
- NN2211-3929
- Other IDs
- U1111-1132-2221
- Status last verified
- Aug 2017
- First submitted
- 27 Mar 2013
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month, Multi-centre, Open Labelled, Non-randomized, Non-interventional, Safety Study of Liraglutide (Victoza®) in Subjects With Type 2 Diabetes Mellitus in Korea
- ClinicalTrials.gov ID
- NCT01821846
- Acronym / sponsor ID
- NN2211-3929
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2013 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 8 Mar 2017 (actual)
- First posted
- 1 Apr 2013 (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 Asia. The aim of this study is to investigate the safety profile of liraglutide (Victoza®) under normal conditions of use in Korean subjects with type 2 diabetes mellitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | – | Drug: liraglutide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Victoza® will be prescribed and titrated by the physician.
Key inclusion criteria (2 listed)
- Subjects with T2DM (Type 2 Diabetes Mellitus), including newly-diagnosed subjects, who require treatment with Victoza® according to the clinical judgment of their treating physician
- Subjects (and/or parents or the subject's legally acceptable representative) who are capable of giving study-specific signed informed consent before any collection of information
Key exclusion criteria (4 listed)
- Subjects with a hypersensitivity to Victoza® or to any of the excipients
- Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods
- Subjects with personal or family history of medullary thyroid carcinoma (MTC)
- Subjects with multiple endocrine neoplasia syndrome type 2 (MEN2)
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 |
|---|---|---|
| liraglutideAdministered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm). | Drug | Liraglutide |
Primary outcome
The incidence of SADRs (Serious Adverse Drug Reactions)
Time frame: Up to 6 months
4 secondary outcomes
HbA1c (Glycosylated haemoglobin) change
Time frame: Month 0, month 6
Percentage of subjects reaching the target of HbA1c below 7.0%
Time frame: Month 6
Change in body weight
Time frame: Month 0, month 6
Number of SAEs/ ADRs (Serious Adverse Events/Adverse Drug Reactions)
Time frame: Up to 6 months
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 21 Aug 2017.
- 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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 7 sites 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 2 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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?
The incidence of SADRs (Serious Adverse Drug Reactions) (time frame: Up to 6 months). 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 21 Aug 2017.