DiabetesNCT02321878
Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®)
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 5 sites in Japan.
Trial summary
This trial is conducted in Asia. The aim of this trial is to evaluate safety and effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination with antidiabetes agents other than sulfonylurea under post-marketing normal clinical practice conditions. 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
- How many people
- 1,092 participants
- Where
- 5 sitesJapan
- Study dates
- 15 Dec 2014to 16 Jun 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: Male or female patients with T2DM who the physician has decided to start on treatment with Victoza® in combination with insulin or oral anti-diabetes drug (OAD) other than SU (Sulfonylurea) will be eligible for this study.
Who may be able to join
- Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
- Patients with T2DM (type 2 diabetes mellitus) who the physician has decided to start treatment with Victoza® in combination with insulin or OAD (oral anti-diabetes drug) other than SU (sulfonylurea)
- Male or female, no age limitation
Who cannot join
- Previous participation in this study or NN2211-3772 Participation is defined as informed consent obtained for this study or enrolment for NN2211-3772
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients who are on Victoza® or have previously been on Victoza® within 3 month before the enrolment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Novo Nordisk Investigational Site
Chichibu, 368-0004
Novo Nordisk Investigational Site
Koriyama-shi, Fukushima, 963 8851
Novo Nordisk Investigational Site
Oyama-shi, Tochigi, 323 0022
Novo Nordisk Investigational Site
Tagajō-shi, 985 0852
Novo Nordisk Investigational Site
Tokyo, 1000005
About this study
This trial is conducted in Asia. The aim of this trial is to evaluate safety and effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination with antidiabetes agents other than sulfonylurea under post-marketing normal clinical practice conditions.
- 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
Liraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions.
No treatment given.
| 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.
Number of AEs (adverse events)
Measured: Week 0-52
Secondary outcomes (2)
Number of adverse reactions (ARs)
Measured: Week 0-52
Change in HbA1c (glycosylated haemoglobin)
Measured: Week 0, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study start15 Dec 2014
- Primary completion16 Jun 2017
- Study completion16 Jun 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
- 1,092 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
- NCT02321878
- Sponsor's protocol ID
- NN2211-4175
- Other IDs
- U1111-1157-6701
- Status last verified
- Aug 2017
- First submitted
- 17 Dec 2014
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance (Special Use-results Surveillance) on Use With Liraglutide (Victoza®)
- ClinicalTrials.gov ID
- NCT02321878
- Acronym / sponsor ID
- NN2211-4175
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,092 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 22 Dec 2014 (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 trial is to evaluate safety and effectiveness of Victoza® in patients with type 2 diabetes mellitus (T2DM) in combination with antidiabetes agents other than sulfonylurea under post-marketing normal clinical practice conditions.
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
- Male or female patients with T2DM who the physician has decided to start on treatment with Victoza® in combination with insulin or oral anti-diabetes drug (OAD) other than SU (Sulfonylurea) will be eligible for this study.
Key inclusion criteria (3 listed)
- Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
- Patients with T2DM (type 2 diabetes mellitus) who the physician has decided to start treatment with Victoza® in combination with insulin or OAD (oral anti-diabetes drug) other than SU (sulfonylurea)
- Male or female, no age limitation
Key exclusion criteria (3 listed)
- Previous participation in this study or NN2211-3772 Participation is defined as informed consent obtained for this study or enrolment for NN2211-3772
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients who are on Victoza® or have previously been on Victoza® within 3 month before the enrolment
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 |
|---|---|---|
| liraglutideLiraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions. No treatment given. | Drug | Liraglutide |
Primary outcome
Number of AEs (adverse events)
Time frame: Week 0-52
2 secondary outcomes
Number of adverse reactions (ARs)
Time frame: Week 0-52
Change in HbA1c (glycosylated haemoglobin)
Time frame: Week 0, week 52
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 1 Sep 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
5 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 5 sites 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 3 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 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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?
Number of AEs (adverse events) (time frame: Week 0-52). 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 1 Sep 2017.