Study identification

EU PAS number

EUPAS20025

Study ID

27527

Official title and acronym

Post-authorization safety study in patients with type 2 diabetes mellitus to assess the incidence of ketoacidosis, severe complications of urinary tract infection, volume depletion, and dehydration among patients treated with EMPAGLIFLOZIN or DPP-4 inhibitors in Saudi Arabia (Post-authorization safety study in type 2 diabetic)

DARWIN EU® study

No

Study countries

Saudi Arabia

Study description

This will be non-interventional study with new data collection. The study will use a “new users” design and compare new users of EMPAGLIFLOZIN to new users of DPP-4 inhibitors. The index date will be defined as the date on which each identified new user receives the index prescription for EMPAGLIFLOZIN or a DPP-4 inhibitor.Number of recruited patients will be comparable in each group within a given timeframe (i.e. each site will ensure to recruit similar number per month for each group). Propensity scores based on information prior to the index date will be used to account for potential confounding.Patients will be follow-up for 12 months after index date.

Study status

Ongoing

Contact details

Ahmed Mansour

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim
Regulatory

Was the study required by a regulatory body?

Yes

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

Non-EU RMP only