DiabetesNCT01403025
Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions). 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
- 4,121 participants
- Where
- 1 siteJapan
- Study dates
- 19 Jul 2011to 28 Dec 2015
- 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: Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who are considered to need treatment with liraglutide (Victoza®)
Who may be able to join
- Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide
Who cannot join
- Subjects who are or have previously been on liraglutide
- Subjects who have previously been enrolled in the study
- Subjects with a hypersensitivity to liraglutide 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 cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial
- Known or suspected abuse of alcohol or narcotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus
This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).
- 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
Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the 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: After 36 months
Secondary outcomes (2)
The incidence rate and type of SAEs (Serious Adverse Events)
Measured: At month 1, 3, 6, 12, 24 and 36
The incidence rate and type of ADRs (Adverse Drug Reactions)
Measured: At month 1, 3, 6, 12, 24 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study start19 Jul 2011
- Primary completion28 Dec 2015
- Study completion28 Dec 2015
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
- 4,121 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
- NCT01403025
- Sponsor's protocol ID
- NN2211-3772
- Other IDs
- U1111-1120-7575, JapicCTI-111559
- Status last verified
- Feb 2018
- First submitted
- 21 Jul 2011
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Victoza® in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01403025
- Acronym / sponsor ID
- NN2211-3772
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,121 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2011 (actual)
- Primary completion
- 28 Dec 2015 (actual)
- Study completion
- 28 Dec 2015 (actual)
- First posted
- 27 Jul 2011 (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 the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).
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
- Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who are considered to need treatment with liraglutide (Victoza®)
Key inclusion criteria (1 listed)
- Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide
Key exclusion criteria (6 listed)
- Subjects who are or have previously been on liraglutide
- Subjects who have previously been enrolled in the study
- Subjects with a hypersensitivity to liraglutide 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 cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the 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 |
|---|---|---|
| liraglutideOnce daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm | Drug | Liraglutide |
Primary outcome
The incidence of SADRs (Serious Adverse Drug Reactions)
Time frame: After 36 months
2 secondary outcomes
The incidence rate and type of SAEs (Serious Adverse Events)
Time frame: At month 1, 3, 6, 12, 24 and 36
The incidence rate and type of ADRs (Adverse Drug Reactions)
Time frame: At month 1, 3, 6, 12, 24 and 36
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 12 Feb 2018.
- 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?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site 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 1 inclusion and 6 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 12 Feb 2018. 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 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?
The incidence of SADRs (Serious Adverse Drug Reactions) (time frame: After 36 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 12 Feb 2018.