Study identification

EU PAS number

EUPAS19769

Study ID

19786

Official title and acronym

Programme of Epidemiological Studies of Lixisenatide and other GLP-1 Receptor Agonists

DARWIN EU® study

No

Study countries

Belgium
Italy

Study description

I. Database study of GLP-1 Receptor Agonists and Risk of Acute Pancreatitis, Pancreatic Cancer and Thyroid Cancer, in Particular Medullary Thyroid Cancer.
This is a retrospective cohort study designed to assess the risk of acute pancreatitis, pancreatic cancer and medullary thyroid cancer associated with use of GLP-1 RA when compared to patients prescribed other types of anti-diabetic drugs. This study will establish the profile of users of GLP-1 RAs and of other anti-diabetic medications. Two cohorts based on prescription databases were established, in Belgium and the Lombardy Region, Italy. Study specific analysis were planned, followed by meta-analyses of the two results.
II. Patient Registry of Lixisenatide Use in Adult Type 2 Diabetes This is a patient registry of patients with diabetes exposed to lixisenatide.
The primary objectives of this study are to monitor the occurrences of acute pancreatitis, pancreatic cancer and thyroid cancer, especially medullary carcinoma of the thyroid, among adult type 2 diabetes patients treated with lixisenatide and to compare their risks with that of users of (1) Other GLP-1 receptor agonists from the Database Study, (2) Other diabetic medications from the Database Study, (3) The general population.

Study status

Ongoing
Research institutions and networks

Institutions

AIM-IMA Brussels, Belgium
CRS-SISS Milano, Italy

Contact details

Peter Boyle

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)