A cohort study to investigate the risk of severe hypoglycemia among diabetic patients treated with Lyumjev® using the Medical Data Vision (MDV) database in Japan (I8B-JE-B003)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104509
• EU PAS number:
  EUPAS104508
• Study ID:
  104509
• Official title and acronym:
  A cohort study to investigate the risk of severe hypoglycemia among diabetic patients treated with Lyumjev® using the Medical Data Vision (MDV) database in Japan (I8B-JE-B003)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Primary Objective To describe the incidence proportion and incidence rate of first severe hypoglycemia requiring any hospital visit among adult patients (≥18-years-old) with diabetes treated with Lyumjev under routine care, and among the following subgroups: patients using (continuous subcutaneous insulin infusion (CSII), patients treated using combination therapy with long-acting insulin analog therapy, patients with a diagnosis of type 1 diabetes, and patients with a diagnosis of type 2 diabetes.
• Study status:
  Planned

Research institutions and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 12/04/2023

Study start date

Planned: 01/12/2019

Date of final study report

Planned: 29/02/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly Japan K.K.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only