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GLP-1 REceptor Agonists and Real World EvIdeNce (GLP-1REWIN)

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ClinicalTrials.gov Identifier: NCT03959865
Recruitment Status : Unknown
Verified May 2019 by University of Padova.
Recruitment status was:  Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Azienda Ospedaliera di Padova
Information provided by (Responsible Party):
University of Padova

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Long-acting GLP-1RA
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

Short-acting GLP-1RA
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

Exendin-based GLP-1RA
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)

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 3-12 months ]
    Change in HbA1c from baseline to end of follow-up

Secondary Outcome Measures :
  1. Weight [ Time Frame: 3-12 months ]
    Change in body weight from baseline to end of follow-up

  2. Blood pressure [ Time Frame: 3-12 months ]
    Change in systolic blood pressure from baseline to end of follow-up

  3. Persistence [ Time Frame: 3-12 months ]
    Percentage of patients who persist on treatment at the end of follow-up

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetic patients attending diabetes specialist clinics in North East Italy.

Inclusion Criteria:

  • Type 2 diabetes
  • Diabetes duration of at least 1 year
  • Initiated on a GLP-1RA during the data collection period

Exclusion Criteria:

  • Type 1 diabetes
  • Previous therapy with a GLP-1RA before the data collection period

Information from the National Library of Medicine

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

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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
Diabetologia ULSS2
Treviso, Italy, 31100
Sponsors and Collaborators
University of Padova
Azienda Ospedaliera di Padova
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Study Chair: Gian Paolo Fadini, MD PhD University of Padova

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT03959865    
Other Study ID Numbers: 4462/AO/18
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no possibility to share data with third parties.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glucagon-Like Peptide 1
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents