DiabetesNCT01484262
Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study is conducted in Europe. The intention of this health service research study is to obtain data from daily routine to evaluate the quality of life and the costs of the disease for patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide and insulin
- How many people
- 1,344 participants
- Where
- 1 siteGermany
- Study dates
- 14 Nov 2011to 31 Oct 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetics (OADs), who need treatment intensification with insulin or liraglutide due to inadequate blood glucose control.
Who may be able to join
- Informed consent obtained before any study-related activities. (Study-related activities are any procedures related to recording of data according to the protocol)
- Patients willing and able to give signed consent on matching patient data with sick fund data
- Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (Victoza®) due to inadequate blood glucose control
- Patient is a member of the involved sick fund (AOK Plus)
Who cannot join
- Known or suspected contra-indication to the relevant study product according to current SPC
- Previous participation in this study
- History of type 1 diabetes mellitus
- Previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days)
- Previous treatment with liraglutide
- History of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis
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- Progressive fatal disease
- Any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse
- Patients without legal capacity
Trial locations and contacts
1 site in 1 country.
About this study
This study is conducted in Europe. The intention of this health service research study is to obtain data from daily routine to evaluate the quality of life and the costs of the disease for patients with type 2 diabetes mellitus.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide, insulin
- 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
Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.
insulinDrug
Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Not described Receives: Drug: liraglutide | |
| Any insulin | Not described Receives: Drug: insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life)
Measured: At the end of the observational period (52 weeks)
Secondary outcomes (2)
Total cost of patient's diseases
Measured: At the end of the observational period (52 weeks)
Total cost of patient education
Measured: At the end of the observational period (52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study start14 Nov 2011
- Primary completion31 Oct 2014
- Study completion31 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,344 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
- NCT01484262
- Sponsor's protocol ID
- NN2211-3962
- Other IDs
- U1111-1123-5044
- Status last verified
- Oct 2018
- First submitted
- 22 Nov 2011
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lundershausen R, Muller S, Hashim M, Kienhofer J, Kipper S, Wilke T. Quality of Life, Glycemic Control, Safety and Tolerability Associated with Liraglutide or Insulin Initiation in Patients with Type 2 Diabetes in Germany: Results from the Prospective, Non-interventional LIBERTY Study. Exp Clin Endocrinol Diabetes. 2020 Mar;128(3):170-181. doi: 10.1055/a-0636-3961. Epub 2018 Aug 29.
PubMed 30157532
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT01484262
- Acronym / sponsor ID
- NN2211-3962
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,344 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2011 (actual)
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 31 Oct 2014 (actual)
- First posted
- 2 Dec 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 study is conducted in Europe. The intention of this health service research study is to obtain data from daily routine to evaluate the quality of life and the costs of the disease for patients with type 2 diabetes mellitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | – | Drug: liraglutide |
| Any insulin | – | Drug: insulin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetics (OADs), who need treatment intensification with insulin or liraglutide due to inadequate blood glucose control.
Key inclusion criteria (4 listed)
- Informed consent obtained before any study-related activities. (Study-related activities are any procedures related to recording of data according to the protocol)
- Patients willing and able to give signed consent on matching patient data with sick fund data
- Patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (Victoza®) due to inadequate blood glucose control
- Patient is a member of the involved sick fund (AOK Plus)
Key exclusion criteria (9 listed)
- Known or suspected contra-indication to the relevant study product according to current SPC
- Previous participation in this study
- History of type 1 diabetes mellitus
- Previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days)
- Previous treatment with liraglutide
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 |
|---|---|---|
| liraglutidePatients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling. | Drug | Liraglutide |
| insulinAny insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling. | Drug | Any insulin |
Primary outcome
Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life)
Time frame: At the end of the observational period (52 weeks)
2 secondary outcomes
Total cost of patient's diseases
Time frame: At the end of the observational period (52 weeks)
Total cost of patient education
Time frame: At the end of the observational period (52 weeks)
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 Nov 2018.
- Results publication: PubMed 30157532Lundershausen R, Muller S, Hashim M, Kienhofer J, Kipper S, Wilke T. Quality of Life, Glycemic Control, Safety and Tolerability Associated with Liraglutide or Insulin Initiation in Patients with Type 2 Diabetes in Germany: Results from the Prospective, Non-interventional LIBERTY Study. Exp Clin Endocrinol Diabetes. 2020 Mar;128(3):170-181. doi: 10.1055/a-0636-3961. Epub 2018 Aug 29.
- 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
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 Germany.
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 9 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 Nov 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 Germany. 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?
Diabetes-related quality of life assessed by ADDQoL (Audit of Diabetes-Dependent Quality of Life) (time frame: At the end of the observational period (52 weeks)). 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 NCT01484262, which also lists 1 linked publication.
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 Nov 2018.