GLP-1 REceptor Agonists and Real World EvIdeNce (GLP-1REWIN)
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|ClinicalTrials.gov Identifier: NCT03959865|
Recruitment Status : Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Glucagon-like peptide-1 receptor agonists (GLP-1RA) are powerful second-line agents for the treatment of type 2 diabetes. GLP-1RA have bene marketed in 2010 in Italy and years of experience have accumulated for the treatment with this class of drugs. Cardiovascular outcome trials have shown that type 2 diabetic patients with established cardiovascular disease treated with GLP-1RA have a lower risk of future cardiovascular events.
In this real world study, we wish to evaluate retrospectively the effectiveness and persistence on treatment of GLP-1RA therapy in patients with type 2 diabetes from 2010 to 2018.
Effectiveness endpoints will be glycemic (fasting plasma glucose and HbA1c) and extra-glycemic (body weight and blood pressure). Data from diabetes outpatient clinics in North East Italy will be automatically extracted from electronic chart records and collected into a unique database.
Different groups of GLP-1RA therapies will be compared:
- Long-acting (e.g. dulaglutide and exenatide once weekly) versus short acting (exenatide, liraglutide and lixisenatide)
- Fixed versus flexible combinations of GLP-1RA and basal insulin.
- GLP-1RA with similarities to human GLP-1 (e.g. liraglutide) versus exendin-based GLP-1RA (e.g. exenatide).
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes||Drug: Long-acting GLP-1RA Drug: Short-acting GLP-1RA Drug: Human-based GLP-1RA Drug: Exendin-based GLP-1RA Drug: Fixed ratio BI/GLP-1RA combination Drug: Flexible BI/GLP-1RA combination|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||6000 participants|
|Official Title:||Effectiveness and Persistence of Therapy With GLP-1 Receptor Agonists in Clinical Practice. A Multicenter Retrospective Study|
|Actual Study Start Date :||December 19, 2018|
|Actual Primary Completion Date :||February 11, 2019|
|Estimated Study Completion Date :||May 31, 2019|
Patients who have been treated with weekly GLP-1RA (exenatide once weekly or dulaglutide)
Drug: Long-acting GLP-1RA
Dulaglutide 0.75 or 1.5 mg /week or Exenatide once weekly 2 mg
Patients who have been treated with daily GLP-1RA (exenatide bid or liraglutide or lixisenatide)
Drug: Short-acting GLP-1RA
Liraglutide 0.6 mg or 1.2 mg or 1.8 mg / day or exenatide 10 mcg or 20 mcg bid or lixisenatide 10 mcg or 20 mcg / day.
Human GLP-1 based GLP-1RA
Patients who have been treated with GLP-1RA based on human GLP-1 (dulaglutide or liraglutide)
Drug: Human-based GLP-1RA
Liraglutide 0.6 mg or 1.2 mg or 1.8 mg / day or dulaglutide 0.75 or 1.5 mg / week
Patients who have been treated with weekly GLP-1RA (exenatide or lixisenatide)
Drug: Exendin-based GLP-1RA
Exenatide 10 mcg or 20 mcg day or 2 mg / week or lixisenatide 10 mcg or 20 mcg / day.
Fixed ratio combination of BI/GLP-1RA
Patients who have been treated with a fixed ratio combination of GLP-1RA and basal insulin (BI), such as IdegLira (insulin degludec / liraglutide) or IglarLixi (insulin glargine / lixisenatide)
Drug: Fixed ratio BI/GLP-1RA combination
Insulin degludec / liraglutide (0.036/U) or insulin glargine / lixisenatide (0.5 mcg/U)
Flexible combination of BI/GLP-1RA
Patients who have been treated with any GLP-1RA in combination with any basal insulin (BI)
Drug: Flexible BI/GLP-1RA combination
GLP-1RA (Liraglutide or dulaglutide or exenatide or lixisenatide) and basal insulin (BI, glargine, degludec, detemir, NPH insulin)
- HbA1c [ Time Frame: 3-12 months ]Change in HbA1c from baseline to end of follow-up
- Weight [ Time Frame: 3-12 months ]Change in body weight from baseline to end of follow-up
- Blood pressure [ Time Frame: 3-12 months ]Change in systolic blood pressure from baseline to end of follow-up
- Persistence [ Time Frame: 3-12 months ]Percentage of patients who persist on treatment at the end of follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959865
|Servizio di Diabetologia UOC Medicina Generale|
|Cittadella, Padova, Italy, 35013|
|U.O.S Diabetologia, Ospedale di Schiavonia|
|Monselice, Padova, Italy, 35043|
|U.O. Diabetologia ULSS2|
|Pieve di Soligo, Treviso, Italy, 31053|
|U.O. Diabetologia e Dietetica ULSS6|
|Padova, Italy, 35100|
|Azienda Ospedaliera di Padova|
|Padova, Italy, 35128|
|Treviso, Italy, 31100|
|Study Chair:||Gian Paolo Fadini, MD PhD||University of Padova|