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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19786
• 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

International Prevention Research Institute (IPRI)

France

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

Study timelines

Date when funding contract was signed

Actual: 30/09/2012

Study start date

Actual: 01/01/2002

Data analysis start date

Actual: 01/07/2015

Date of interim report, if expected

Actual: 12/06/2016

Date of final study report

Planned: 23/10/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Initial protocol

lixisenatide-epidemiologic-study-protocol-2013-12-02-final

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)