Study identification

PURI

https://redirect.ema.europa.eu/resource/27897

EU PAS number

EUPAS21696

Study ID

27897

Official title and acronym

A 5-year enhanced Pharmacovigilance surveillance initiative to survey and characterise spontaneous occurrence and experience of ketoacidotic events in patients treated with Empagliflozin –containing products

DARWIN EU® study

No

Study countries

Argentina
Aruba
Australia
Austria
Bahamas
Bahrain
Barbados
Belarus
Belgium
Bermuda
Bosnia and Herzegovina
Botswana
Brazil
Brunei Darussalam
Bulgaria
Canada
Cayman Islands
Chile
China
Colombia
Costa Rica
Croatia
Cuba
Cyprus
Czechia
Denmark
Dominican Republic
Ecuador
Egypt
El Salvador
Estonia
Finland
France
Germany
Greece
Guatemala
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Korea, Republic of
Kuwait
Latvia
Lebanon
Liechtenstein
Lithuania
Luxembourg
Macau
Malaysia
Malta
Mexico
Morocco
Namibia
Netherlands
Netherlands Antilles
New Zealand
North Macedonia
Norway
Panama
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
Romania
Russian Federation
Saudi Arabia
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Sweden
Switzerland
Taiwan
Thailand
Türkiye
Ukraine
United Arab Emirates
United Kingdom
United States
Uruguay
Viet Nam

Study description

The rationale behind this initiative is to perform surveillance of spontaneous adverse event reports from post-marketed experience of ketoacidosis as well as:1) To better describe characteristics of patients developing KA under empagliflozin treatment.2) To characterise potential predisposing factors in patients developing KA under empagliflozin treatment.3) To characterize the clinical presentation of KA in patients taking empagliflozin treatment.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Fernando Solimando

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 interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim
Study protocol
Initial protocol

1245.146 FINAL PROTOCOL VER 01 28 JUN 2016

English (263.45 KB - PDF)View document
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)