DiabetesNCT02077946
A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Sweden.
Trial summary
This trial is conducted in Europe. The aim of this study is to investigate a retrospective database assessment of clinical effectiveness in type 2 diabetes patients treated with liraglutide from primary care centers in Sweden. 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?
- liraglutide and sitagliptin
- How many people
- 1,059 participants
- Where
- 1 siteSweden
- Study dates
- 10 Feb 2014to 3 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data will be analyzed for patients with type 2 diabetes treated with liraglutide or sitagliptin from January 2010 to December 2013, with a treatment length of 180 days.
Who may be able to join
- Patients from EMR (electronic medical record) system in the primary care in Sweden
- Patients equal to or more than 18 years of age
- Starting treatment with liraglutide or sitagliptin from January 2010 to December 2013
- Minimum of 180 days of prior follow-up/history within the database before their index date
Who cannot join
- Patients with cancer, end stage liver disease, end stage renal failure (non-diabetes related)
- Female patients with gestational diabetes during pregnancy
- Patients with previous GLP-1 (glucagon-like peptide-1) or DPP-IV (dipeptidyl peptidase-4 ) inhibitor use, i.e. patients should be incretin naïve
Trial locations and contacts
1 site in 1 country.
About this study
This trial is conducted in Europe. The aim of this study is to investigate a retrospective database assessment of clinical effectiveness in type 2 diabetes patients treated with liraglutide from primary care centers in Sweden.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide, sitagliptin
- 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
No treatment given.
sitagliptinDrug
No treatment given.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide / Sitagliptin | Not described Receives: Drug: liraglutide; Drug: sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) of patients achieving at least 1 %-point HbA1c (glycosylated haemoglobin) reduction
Measured: Day 0, Day 180
Secondary outcomes (6)
Percent (%) of patients with HbA1c (glycosylated haemoglobin) reduction at least 1 %-point and weight reduction at least 3% (NICE clinical guidelines, liraglutide only)
Measured: Day 0, Day 180
HbA1c (NGSP standard, in %) change
Measured: Day 0, Day 180
Change in weight (in kilograms)
Measured: Day 0, Day 180
Change in blood pressure (systolic, in mmHg)
Measured: From baseline to 180 days of therapy
Change in lipids (HDL, LDL and triglycerides, in mmol/L)
Measured: Day 0, Day 180
Change in creatinine
Measured: Day 0, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study start10 Feb 2014
- Primary completion3 Sep 2014
- Study completion3 Sep 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
- Retrospective
- Enrolment
- 1,059 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
- NCT02077946
- Sponsor's protocol ID
- NN2211-4161
- Other IDs
- U1111-1151-9632
- Status last verified
- May 2017
- First submitted
- 28 Feb 2014
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lind M, Matsson PO, Linder R, Svenningsson I, Jorgensen L, Ploug UJ, Gydesen H, Dorkhan M, Larsen S, Johansson G. Clinical Effectiveness of Liraglutide vs Sitagliptin on Glycemic Control and Body Weight in Patients with Type 2 Diabetes: A Retrospective Assessment in Sweden. Diabetes Ther. 2016 Jun;7(2):321-33. doi: 10.1007/s13300-016-0173-z. Epub 2016 May 23.
PubMed 27216947
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden
- ClinicalTrials.gov ID
- NCT02077946
- Acronym / sponsor ID
- NN2211-4161
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,059 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2014 (actual)
- Primary completion
- 3 Sep 2014 (actual)
- Study completion
- 3 Sep 2014 (actual)
- First posted
- 4 Mar 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 Europe. The aim of this study is to investigate a retrospective database assessment of clinical effectiveness in type 2 diabetes patients treated with liraglutide from primary care centers in Sweden.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide / Sitagliptin | – | Drug: liraglutide, Drug: sitagliptin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be analyzed for patients with type 2 diabetes treated with liraglutide or sitagliptin from January 2010 to December 2013, with a treatment length of 180 days.
Key inclusion criteria (4 listed)
- Patients from EMR (electronic medical record) system in the primary care in Sweden
- Patients equal to or more than 18 years of age
- Starting treatment with liraglutide or sitagliptin from January 2010 to December 2013
- Minimum of 180 days of prior follow-up/history within the database before their index date
Key exclusion criteria (3 listed)
- Patients with cancer, end stage liver disease, end stage renal failure (non-diabetes related)
- Female patients with gestational diabetes during pregnancy
- Patients with previous GLP-1 (glucagon-like peptide-1) or DPP-IV (dipeptidyl peptidase-4 ) inhibitor use, i.e. patients should be incretin naïve
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 |
|---|---|---|
| liraglutideNo treatment given. | Drug | Liraglutide / Sitagliptin |
| sitagliptinNo treatment given. | Drug | Liraglutide / Sitagliptin |
Primary outcome
Percent (%) of patients achieving at least 1 %-point HbA1c (glycosylated haemoglobin) reduction
Time frame: Day 0, Day 180
6 secondary outcomes
Percent (%) of patients with HbA1c (glycosylated haemoglobin) reduction at least 1 %-point and weight reduction at least 3% (NICE clinical guidelines, liraglutide only)
Time frame: Day 0, Day 180
HbA1c (NGSP standard, in %) change
Time frame: Day 0, Day 180
Change in weight (in kilograms)
Time frame: Day 0, Day 180
Change in blood pressure (systolic, in mmHg)
Time frame: From baseline to 180 days of therapy
Change in lipids (HDL, LDL and triglycerides, in mmol/L)
Time frame: Day 0, Day 180
Change in creatinine
Time frame: Day 0, Day 180
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 31 May 2017.
- Background: PubMed 27216947Lind M, Matsson PO, Linder R, Svenningsson I, Jorgensen L, Ploug UJ, Gydesen H, Dorkhan M, Larsen S, Johansson G. Clinical Effectiveness of Liraglutide vs Sitagliptin on Glycemic Control and Body Weight in Patients with Type 2 Diabetes: A Retrospective Assessment in Sweden. Diabetes Ther. 2016 Jun;7(2):321-33. doi: 10.1007/s13300-016-0173-z. Epub 2016 May 23.
- 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 Sweden.
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 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 31 May 2017. 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 Sweden. 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?
Percent (%) of patients achieving at least 1 %-point HbA1c (glycosylated haemoglobin) reduction (time frame: Day 0, Day 180). 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 NCT02077946, 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 31 May 2017.