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)

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:
  Finalised

Research institutions and networks

No information provided.

Study timelines

Date when funding contract was signed

Planned:22/12/2016

Actual:26/12/2016

Study start date

Planned:30/09/2018

Actual:27/09/2018

Data analysis start date

Planned:30/06/2020

Date of final study report

Planned:31/12/2020

Actual:14/09/2021

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

Other study registration identification numbers and links

1245-0149; NCT03764631
SFDA application no. 17062102 on SCTR