DiabetesNCT01890993
Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 4 sites in 4 countries.
Trial summary
This study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe. 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
- 952 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2013to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with type 2 diabetes initiated on liraglutide or a DPP-4 inhibitor and primarily managed in primary care with 12 (+/-2) months of available data will be included in this study. Only data derived from patients receiving either therapy in accordance with license indications will be included and analyzed.
Who may be able to join
- Patients treated with liraglutide or DPP-4 inhibitors, according to license in respective participating country with data available for 12 (+/- 2) months
Who cannot join
- Patients treated with liraglutide or DPP-4 inhibitors, outside of license in respective participating country
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
This study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe.
- 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
Anonymised patient level data will be collected by the patients' own general practitioner and electronic case report form (eCRF) will be used to capture the data.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Not described Receives: Drug: liraglutide | |
| DPP-4 | Not described Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (glycosylated haemoglobin)
Measured: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
Secondary outcomes (2)
Change in body weight
Measured: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
Change in systolic blood pressure
Measured: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionJun 2014
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
- Retrospective
- Enrolment
- 952 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
- NCT01890993
- Sponsor's protocol ID
- NN2211-4077
- Other IDs
- U1111-1142-2764, ENCEPP/SDPP/8135
- Status last verified
- May 2015
- First submitted
- 27 Jun 2013
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Collection of Effectiveness and Safety Data From Patients Treated With Liraglutide or DPP-4 Inhibitor in Primary Care in Europe
- ClinicalTrials.gov ID
- NCT01890993
- Acronym / sponsor ID
- NN2211-4077
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Jul 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 study is conducted in Europe. The aim of this study is to demonstrate the clinical effectiveness and safety of liraglutide and dipeptidyl peptidase-4 (DPP-4) inhibitor therapy in routine primary care in Europe.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | – | Drug: liraglutide |
| DPP-4 | – | Drug: liraglutide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with type 2 diabetes initiated on liraglutide or a DPP-4 inhibitor and primarily managed in primary care with 12 (+/-2) months of available data will be included in this study. Only data derived from patients receiving either therapy in accordance with license indications will be included and analyzed.
Key inclusion criteria (1 listed)
- Patients treated with liraglutide or DPP-4 inhibitors, according to license in respective participating country with data available for 12 (+/- 2) months
Key exclusion criteria (1 listed)
- Patients treated with liraglutide or DPP-4 inhibitors, outside of license in respective participating country
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 |
|---|---|---|
| liraglutideAnonymised patient level data will be collected by the patients' own general practitioner and electronic case report form (eCRF) will be used to capture the data. | Drug | DPP-4, Liraglutide |
Primary outcome
Change in HbA1c (glycosylated haemoglobin)
Time frame: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
2 secondary outcomes
Change in body weight
Time frame: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
Change in systolic blood pressure
Time frame: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)
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 May 2015.
- 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
4 sites in 4 countries: 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 4 sites in 4 countries.
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 1 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 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Spain, United Kingdom. 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?
Change in HbA1c (glycosylated haemoglobin) (time frame: Baseline (anytime within 3 months before therapy initiation), month 12 (+/-2)). 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 May 2015.