GLP-1 REceptor Agonists and Real World EvIdeNce

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).

Conditions

• Type 2 Diabetes

Interventions

DRUG

Long-acting GLP-1RA

Dulaglutide 0.75 or 1.5 mg /week or Exenatide once weekly 2 mg

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.

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

DRUG

Exendin-based GLP-1RA

Exenatide 10 mcg or 20 mcg day or 2 mg / week or lixisenatide 10 mcg or 20 mcg / day.

DRUG

Fixed ratio BI/GLP-1RA combination

Insulin degludec / liraglutide (0.036/U) or insulin glargine / lixisenatide (0.5 mcg/U)

DRUG

Flexible BI/GLP-1RA combination

GLP-1RA (Liraglutide or dulaglutide or exenatide or lixisenatide) and basal insulin (BI, glargine, degludec, detemir, NPH insulin)

Sponsors & Collaborators

• Azienda Ospedaliera di Padova

  collaborator OTHER

• University of Padova

  lead OTHER

Principal Investigators

• Gian Paolo Fadini, MD PhD · University of Padova

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-19

Primary Completion

2019-02-11

Completion

2019-05-31

Countries

• Italy

Study Locations