Study identification

EU PAS number

EUPAS39461

Study ID

42437

Official title and acronym

A Meta-Analysis of Amputation Risk in empagliflozin studies (1245.25, 1245.110, 1245.121)

DARWIN EU® study

No

Study countries

Argentina
Australia
Austria
Belgium
Brazil
Canada
Colombia
Croatia
Czechia
Denmark
Estonia
France
Georgia
Germany
Greece
Hong Kong
Hungary
India
Indonesia
Israel
Italy
Japan
Korea, Republic of
Malaysia
Mexico
Netherlands
New Zealand
Norway
Peru
Philippines
Poland
Portugal
Romania
Russian Federation
Singapore
South Africa
Spain
Sri Lanka
Taiwan
Thailand
Ukraine
United Kingdom
United States

Study description

The primary objective of this exploratory meta-analysis is to evaluate the frequencies, incidence rates, and hazard ratios of lower-limb amputation (LLA) events (primary outcome) and of adverse events related to amputation (secondary outcome) in patients treated with empagliflozin compared with placebo in the pooled population of the long-term studies 1245.25, 1245.110, and 1245.121 (SAF-M1), in the pooled population of studies 1245.110 and 1245.121 (SAFM2), and in each of the 3 studies separately.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 999 centres are involved in the study

Contact details

Hristo Iliev

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim International GmbH
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)