Status: Finalised First registered on: 25/04/2018
Last updated on: 30/03/2020
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 typeObservational study
Brief description of the studyThis is an international, multi-centre observational, real world evidence study. This study will be conducted in 4 to 8 mental health centres in the United Kingdom (UK), Netherlands and Switzerland. The study is based on both retrospective and prospective collection of data from patients’ medical records. It is a single group study without a comparator, to reflect real world clinical practice. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required. The population for this study is adult patients diagnosed with schizophrenia who received treatment with a medicine called lurasidone as part of their standard clinical care. It is expected to recruit 80 patients in total. The main purpose is to find out more about how lurasidone is used to treat patients with schizophrenia in the real world and how well it works.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableNP-LAT-721-18
2. Research centres and Investigator details
Coordinating study entity
Centre nameDr Andrew Jones
Centre locationSunovion Pharmaceuticals Europe Ltd.
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
Multiple centres

In total how many centres are involved in this Study?5
Countries in which this study is being conducted
International study

Netherlands
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/10/201718/10/2017
Start date of data collection04/02/201912/02/2019
Start date of data analysis29/05/2020
Date of interim report, if expected
Date of final study report31/08/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSunovion Pharmaceuticals Europe100
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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