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Trial · Observational

Status unknownPhase not statedRegistry data

GLP-1 REceptor Agonists and Real World EvIdeNce

Short name GLP-1REWIN

This trial does not test a peptide that PepBank tracks.

  • Names Dulaglutide (Trulicity), does not test it. It appears in the summary.
  • Names Exenatide (exendin-4), does not test it. It appears in the summary.
  • Names Liraglutide, does not test it. It appears in the summary.
  • Names Lixisenatide, does not test it. It appears in the summary.

Overview

Status
Status unknown
Phase
Phase not stated
Enrollment
6,000 participants (estimated)
Sponsor
University of Padova · Other
Design
Not stated
Countries
1 country

Italy

Start
19 Dec 2018
Primary completion
11 Feb 2019
Completion
31 May 2019 (estimated)
First posted
22 May 2019
Last update posted
22 May 2019
Conditions
Type 2 Diabetes

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph –

    GLP-1REWIN

    NCT03959865

    19 Dec 2018 to est. 31 May 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Long-acting GLP-1RADrug
  • Short-acting GLP-1RADrug
  • Human-based GLP-1RADrug
  • Exendin-based GLP-1RADrug
  • Fixed ratio BI/GLP-1RA combinationDrug
  • Flexible BI/GLP-1RA combinationDrug

Arms6

  • Other

    Long-acting GLP-1RA

    Patients who have been treated with weekly GLP-1RA (exenatide once weekly or dulaglutide)

  • Other

    Short-acting GLP-1RA

    Patients who have been treated with daily GLP-1RA (exenatide bid or liraglutide or lixisenatide)

  • Other

    Human GLP-1 based GLP-1RA

    Patients who have been treated with GLP-1RA based on human GLP-1 (dulaglutide or liraglutide)

  • Other

    Exendin-based GLP-1RA

    Patients who have been treated with weekly GLP-1RA (exenatide or lixisenatide)

  • Other

    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)

  • Other

    Flexible combination of BI/GLP-1RA

    Patients who have been treated with any GLP-1RA in combination with any basal insulin (BI)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. HbA1c

    Time frame · 3-12 months

    Registry description

    Change in HbA1c from baseline to end of follow-up

Secondary outcomes(3)
  1. Weight

    Time frame · 3-12 months

    Registry description

    Change in body weight from baseline to end of follow-up

  2. Blood pressure

    Time frame · 3-12 months

    Registry description

    Change in systolic blood pressure from baseline to end of follow-up

  3. Persistence

    Time frame · 3-12 months

    Registry description

    Percentage of patients who persist on treatment at the end of follow-up

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Meta-analysis (pooled) · 2018

22 results

Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis.

Bethel et al. 2018The lancet. Diabetes & endocrinologycited by 476

PMID 29221659DOI 10.1016/s2213-8587(17)30412-6PUB-29221659

Rights unknown22 results

Indexing hint: Meta-analysis (pooled) · 2017

2 results

Glucagon-like peptide-1 receptor agonists compared with basal insulins for the treatment of type 2 diabetes mellitus: a systematic review and meta-analysis.

Singh et al. 2017Diabetes, obesity & metabolismcited by 84

PMID 27717130PMC5299485DOI 10.1111/dom.12805PUB-27717130

Free to read · publisher termsCC BY-NC2 results

Indexing hint: Meta-analysis (pooled) · 2017

9 results

A meta-analysis comparing clinical effects of short- or long-acting GLP-1 receptor agonists versus insulin treatment from head-to-head studies in type 2 diabetic patients.

Abd El Aziz et al. 2017Diabetes, obesity & metabolismcited by 116

PMID 27717195DOI 10.1111/dom.12804PUB-27717195

Full text at the publisher9 results

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedMorieri ML, Rigato M, Frison V, Simioni N, D'Ambrosio M, Tadiotto F, Paccagnella A, Lapolla A, Avogaro A, Fadini GP. Fixed versus flexible combination of GLP-1 receptor agonists with basal insulin in type 2 diabetes: A retrospective multicentre comparative effectiveness study. Diabetes Obes Metab. 2019 Nov;21(11):2542-2552. doi: 10.1111/dom.13840. Epub 2019 Aug 12. PMID 31364233

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not stated
Inclusion and exclusion criteria, as posted
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

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