Status: FinalisedLast updated on: 01/11/2018
1. Study identification
EU PAS Register NumberEUPAS23705
Official titleIncidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes Mellitus Treated with SGLT2 inhibitors or Other Antihyperglycemic Agents- A Retrospective, Observational, New-User Cohort Study Using 4 Administrative Claims Databases in the US
Study title acronym
Study typeOther: observational, retrospective, new user cohort study
Brief description of the study
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameJanssen Research & Development, LLC
Centre locationTitusville, NJ, USA
Details of (Primary) lead investigator
Title Dr
Last name Wang
First name Lu
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/04/201818/04/2018
Start date of data collection18/04/201818/04/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report08/10/201801/10/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesJanssen Research & Development, LLC100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Wang
First name Lu
Address line 11125 Trenton-Harbourton Road
Address line 2 
Address line 3 
CityTitusville, NJ 
Postcode 
CountryUnited States
Phone number (incl. country code)16097303007 
Alternative phone number 
Fax number (incl. country code) 
Email address lwang284@its.jnj.com
Public Enquiries
Title Dr 
Last name Wang 
First name Lu 
Address line 11125 Trenton-Harbourton Road 
Address line 2 
Address line 3 
CityTitusville, NJ 
Postcode 
CountryUnited States 
Phone number (incl. country code)16097303007 
Alternative phone number 
Fax number (incl. country code) 
Email address lwang284@its.jnj.com 
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