Diabetes Mellitus Type 2Phase 4EGLIPANCT02501850
The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)
A Phase 4 study testing Liraglutide and metformin in people with Diabetes Mellitus Type 2, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Lipoprotein (a) [Lp (a)] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of CVR. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Liraglutide and metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Oct 2015
- Phase
- Phase 4
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- age between 50-65 years
- written informed consent
Who cannot join
- active GLP-1R agonist, insulin or DPP-IV treatment.
- Liver failure (3lsn AST and/or ALT)
- Kidney failure (FG <30ml/min/1,73m2),
- HbA1c> 10%
- LDL-cholesterol> 180 mg/dl
- Triglycerides> 350 mg/dl
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Andreea Ciudin, PhD, +34932744736, aciudin@vhebron.net
Cristina Hernandez, MD, PhD, +34 932746591, cristina.hernandez@vhir.org
About this study
Lipoprotein (a) [Lp (a)] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp (a) in hepatocytes. The objective of the study is to test in humans the results observed in vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.
Read the detailed description
Background: Lipoprotein (a) [Lp (a)] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp (a) in hepatocytes.
Hypothesis: Treatment with GLP-1R agonists will lower the levels of Lp (a) in patients with DM-2.
Objective: The objective of the study is to confirm in humans the results observed in vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.
Methods: we will evaluate 40 patients with DM-2 treated at the Endocrinology Department of the Vall d'Hebron University Hospital. The patients will be distributed in two groups according to the treatment prescribed by the endocrinologist during the visit of routine monitoring: group A (20 patients who were prescribred treatment with GLP-1R agonists) and group B (20 patients who were not prescribed this treatment). According to the current guidelines for treating DM-2, the GLP-1R agonists are situated as a second line treatment after metformin, and the treatment should be individualized according to the characteristics of each patient. (Inzucchi et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Diabetes Care 2012; 35 (6):.. 1364-1379). Following these recommendations, the GLP-1R agonists are usually selected when there is obesity and / or very important to avoid hypoglycaemia. The decision to prescribe a GLP-1R agonist is made by the endocrinologist before and independently of the patient´s participation in the study.
Blood levels of Lp(a) will be evaluated at baseline and at 2 months (+/- 15 days). Diabetic patients who are treated with insulin, enzyme inhibitors DPP-4 (IDDP-4) or already treated with receptor agonists GLP-1, presenting with kidney and liver failure, HbA1c> 10%, LDL-cholesterol> 180 mg / dl and / or triglycerides> 350 mg / dl will excluded.
Relevance: The results will identify a potential treatment for lowering levels of Lp (a) in patients with DM-2 and thus reducing cardiovascular risk associated with this lipoprotein.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Liraglutide, metformin
- Keywords
- Lipoprotein (a)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Exenatide, Lixisenatide
Treatment with liraglutide, exenatide or lixisenatide
metforminDrug
Also called sulphonilurea
Treatment with metformin and/or sulphonilurea
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Type 2 diabetic patients whom were prescribed GLP-1R agonists by the endocrinologist, according to usual clinical practice (liraglutide, exenatide, lixisenatide). The intervention is the prescription of an GLP-1R agonist (liraglutide, exenatide, lixisenatide) Receives: Drug: Liraglutide |
| Group B | Active comparator | Type 2 diabetic patients whom were prescribed metformin and/or sulphonilurea, according to usual clinical practice. Receives: Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood levels of Lipoprotein (a) (Lp(a))
Measured: Baseline and two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501850
- Sponsor's protocol ID
- VHI-GLP-2014-01
- Acronym
- EGLIPA
- Status last verified
- Jul 2015
- First submitted
- 16 Jul 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hernandez C, Francisco G, Chacon P, Simo R. Lipoprotein(a) as a risk factor for cardiovascular mortality in type 2 diabetic patients: a 10-year follow-up study. Diabetes Care. 2005 Apr;28(4):931-3. doi: 10.2337/diacare.28.4.931. No abstract available.
PubMed 15793200Hernandez C, Francisco G, Chacon P, Mesa J, Simo R. Biological variation of lipoprotein(a) in a diabetic population. Analysis of the causes and clinical implications. Clin Chem Lab Med. 2003 Aug;41(8):1075-80. doi: 10.1515/CCLM.2003.166.
PubMed 12964817Genser B, Dias KC, Siekmeier R, Stojakovic T, Grammer T, Maerz W. Lipoprotein (a) and risk of cardiovascular disease--a systematic review and meta analysis of prospective studies. Clin Lab. 2011;57(3-4):143-56.
PubMed 21500721
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)
- ClinicalTrials.gov ID
- NCT02501850
- Acronym / sponsor ID
- EGLIPA / VHI-GLP-2014-01
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Lipoprotein (a)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 17 Jul 2015 (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.
Lipoprotein (a) [Lp (a)] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp (a) in hepatocytes. The objective of the study is to test in humans the results observed in vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.
Detailed description
Background: Lipoprotein (a) [Lp (a)] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp (a) in hepatocytes.
Hypothesis: Treatment with GLP-1R agonists will lower the levels of Lp (a) in patients with DM-2.
Objective: The objective of the study is to confirm in humans the results observed in vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.
Methods: we will evaluate 40 patients with DM-2 treated at the Endocrinology Department of the Vall d'Hebron University Hospital. The patients will be distributed in two groups according to the treatment prescribed by the endocrinologist during the visit of routine monitoring: group A (20 patients who were prescribred treatment with GLP-1R agonists) and group B (20 patients who were not prescribed this treatment). According to the current guidelines for treating DM-2, the GLP-1R agonists are situated as a second line treatment after metformin, and the treatment should be individualized according to the characteristics of each patient. (Inzucchi et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Diabetes Care 2012; 35 (6):.. 1364-1379). Following these recommendations, the GLP-1R agonists are usually selected when there is obesity and / or very important to avoid hypoglycaemia. The decision to prescribe a GLP-1R agonist is made by the endocrinologist before and independently of the patient´s participation in the study.
Blood levels of Lp(a) will be evaluated at baseline and at 2 months (+/- 15 days). Diabetic patients who are treated with insulin, enzyme inhibitors DPP-4 (IDDP-4) or already treated with receptor agonists GLP-1, presenting with kidney and liver failure, HbA1c> 10%, LDL-cholesterol> 180 mg / dl and / or triglycerides> 350 mg / dl will excluded.
Relevance: The results will identify a potential treatment for lowering levels of Lp (a) in patients with DM-2 and thus reducing cardiovascular risk associated with this lipoprotein.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: LiraglutideType 2 diabetic patients whom were prescribed GLP-1R agonists by the endocrinologist, according to usual clinical practice (liraglutide, exenatide, lixisenatide). The intervention is the prescription of an GLP-1R agonist (liraglutide, exenatide, lixisenatide) |
| Group B | Active comparator | Drug: metforminType 2 diabetic patients whom were prescribed metformin and/or sulphonilurea, according to usual clinical practice. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes
- age between 50-65 years
- written informed consent
Key exclusion criteria (6 listed)
- active GLP-1R agonist, insulin or DPP-IV treatment.
- Liver failure (3lsn AST and/or ALT)
- Kidney failure (FG <30ml/min/1,73m2),
- HbA1c> 10%
- LDL-cholesterol> 180 mg/dl
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 |
|---|---|---|
| LiraglutideAlso: Exenatide, LixisenatideTreatment with liraglutide, exenatide or lixisenatide | Drug | Group A |
| metforminAlso: sulphonilureaTreatment with metformin and/or sulphonilurea | Drug | Group B |
Primary outcome
Change in blood levels of Lipoprotein (a) (Lp(a))
Time frame: Baseline and two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Background: PubMed 15793200Hernandez C, Francisco G, Chacon P, Simo R. Lipoprotein(a) as a risk factor for cardiovascular mortality in type 2 diabetic patients: a 10-year follow-up study. Diabetes Care. 2005 Apr;28(4):931-3. doi: 10.2337/diacare.28.4.931. No abstract available.
- Background: PubMed 12964817Hernandez C, Francisco G, Chacon P, Mesa J, Simo R. Biological variation of lipoprotein(a) in a diabetic population. Analysis of the causes and clinical implications. Clin Chem Lab Med. 2003 Aug;41(8):1075-80. doi: 10.1515/CCLM.2003.166.
- Background: PubMed 21500721Genser B, Dias KC, Siekmeier R, Stojakovic T, Grammer T, Maerz W. Lipoprotein (a) and risk of cardiovascular disease--a systematic review and meta analysis of prospective studies. Clin Lab. 2011;57(3-4):143-56.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide and metformin in people with Diabetes Mellitus Type 2, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 21 Jul 2015. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Hernandez, MD, PhD (+34 934894172 ext. 4172, cristina.hernandez@vhir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood levels of Lipoprotein (a) (Lp(a)) (time frame: Baseline and two months). 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 NCT02501850, which also lists 3 linked publications.
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 Jul 2015.