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. 2021 Mar 4;2021(3):CD013498. doi: 10.1002/14651858.CD013498.pub2
Included studies Date study author contacted Date study author replied Type of additional information Type of additional data
Bartley 2008 11 December 2019 No reply
BEGIN Basal‐Bolus Type 1 15 January 2020 19 January 2020: Dr Heller replied that he would like to try to help with the request Additional data No reply with additional data
BEGIN Flex T1 21 January 2020 No reply
BEGIN Young  6 February 2020  No reply
Bolli 2009 11 December 2019 11 December 2019: would like to help, but did no longer have access to study data Study protocol, 'Risk of bias' items, data on safety, additional data Replied 13 December 2019: no additional data provided
Chase 2008 19 February 2020 No reply
Davies 2014 9 December 2019 30 December 2019: Novo Nordisk received the request from Dr. Davies and assured assistance Study protocol, 'Risk of bias' items, data on safety, additional data 20 January 2020: Novo Nordisk provided additional data
Fulcher 2005 8 December 2019 Corresponding author was initially contacted. Due to lack of response, Sanofi was contacted on 29 January 2020 (replied same day that they would look further into the request) Study protocol, 'Risk of bias' items, data on safety, additional data 31 January 2020: CSR was provided
Heller 2009 12 December 2019 Replied 19 January 2020 that he would try to help. As no further action, Novo Nordisk was contacted Study protocol, 'Risk of bias' items, data on safety, additional data Novo Nordisk provided CSR
Home 2005 12 December 2019 12 December 2019: would try to help, although data were old Study protocol, 'Risk of bias' items, data on safety, additional data Comments on data and suggestions
Kobayashi 2007 No contact information retrieved 21 March 2020: Novo Nordisk was contacted Study protocol, 'Risk of bias' items, data on safety, additional data 26 May 2020: translated pages from CSRs provided
Liu 2016 17 February 2020 No reply from study authors. Sanofi was contacted 23/3‐20. Asked for study protocol, 'Risk of bias' items and outcomes 26 March 2020: Sanofi provided CSR
NCT00595374 27 January 2020: Novo Nordisk was asked if the study was published 28 January 2020: Novo Nordisk replied they would look into the request Asked for additional information No CSR or additional information could be provided
NCT00605137 28 February 2020: Novo Nordisk was asked if the study was published 2 March 2020: Novo Nordisk replied they would look further into the request. Replied 9 March 2020 that CSR was only available in Japanese, but they were willing to provide some translated pages. Asked for study protocol, 'Risk of bias' items and outcomes 24 May 2020: pages from CSR provided, study protocol provided
Pieber 2007 25 January 2020 No reply by the investigators, Novo Nordisk was contacted Study protocol, 'Risk of bias' items, data on safety, additional data Novo Nordisk provided CSR
Porcellati 2004 12 December 2019 11 December 2019: would like to help, but did no longer have access to study data NA NA
PRESCHOOL 19 February 2020 No reply from investigators. Sanofi was contacted. 'Risk of bias' items, outcomes Sanofi provided CSR
Ratner 2000 13 January 2020: no reply
12 February 2020: Sanofi contacted
12 February 2020: Sanofi replied they were willing to assist Study protocol, 'Risk of bias' items, data on safety, additional data 14 February 2020: Sanofi provided CSR
Robertson 2007 12 February 2020 12 February 2020: investigator did not have access to the data (retired). Novo Nordisk was contacted 'Risk of bias' items, additional data 12 February 2020: Novo Nordisk provided CSR
Russell‐Jones 2004 16 January 2020 19 January 2020: authors would like to help, but never replied. Novo Nordisk was contacted. Study protocol, 'Risk of bias' items, data on safety, additional data Novo Nordisk provided CSR
Schober 2002 17 February 2020 No reply from authors. Sanofi was contacted 'Risk of bias' items, additional data Sanofi provided CSR
Standl 2004 28 November 2019: no reply; 29 January 2020: Novo Nordisk was contacted No reply from investigator, Novo Nordisk was contacted 'Risk of bias' items, additional data Novo Nordisk provided CSR
SWITCH 1 28 January 2020 1 February 2020: corresponding author replied that they would like to help. As investigator did not have access to data, Novo Nordisk was contacted Data before cross‐over 24 March 2020: Novo Nordisk replied that the requested analyses for data before cross‐over were not performed
Thalange 2013 21 February 2020 No reply
Urakami 2017 12 February 2020 14 February 2020: corresponding author replied they would like to help Study protocol, 'Risk of bias' items, data before cross‐over No study protocol provided, but provided data on outcomes
Vague 2003 23 January 2020: no valid contact information available for the first author; Novo Nordisk was contacted 25 January 2020: Novo Nordisk replied that they would assist Study protocol, 'Risk of bias' items, data on safety, additional data Novo Nordisk provided CSR
Studies awaiting assessment Study completion date Date study author contacted Date study author replied Type of additional information Type of additional data
Basal Analog Study RT/CA 11 February 2020: asked for full‐text publication of study 11 February 2020: study never published. A new request if data could be provided. 11 February 2020: no additional data provided NA
EudraCT 2007‐004144‐74 RT 11 February 2020: asked if full‐text publication was available and duration of the intervention 12/2‐20 ‐ investigator replied that no full‐text article was currently available, but might be in the future. No reply on duration of intervention NA NA
IRCT201203079224N1 RT 11 February 2020: asked for status of study No reply
J‐Collection RT 11 February 2020: asked for status of study No reply
Mianowska 2007 PM 17 February 2020: asked for data before cross‐over No reply
NCT00564018 RT 11 February 2020: asked for status of study No reply
NCT01854723 RT 12 February 2020: investigator asked for full‐text publication or data on study No reply
UMIN000001562 RT 12 February 2020: asked for study duration and full‐text No reply
UMIN000020521 RT 11 February 2020: asked for status of study No reply
UMIN000021046 RT 11 February 2020: asked for status of study No reply
Excluded studies Study completion date Date study author contacted Date study author replied Date study author was asked for additional information
(short summary) Date study author provided data
(short summary)
Orchard 2014 CA 11 February 2020: asked for full‐text publication of study 26 February 2020: investigator replied that no full‐text publication was planned. On the same day, the author was asked if additional information could be provided ‐ study protocol and power point presentation provided by the authors Information about study design and data, publications of study Based on information from investigator, the study could be excluded
—: denotes not reported
CA: conference abstract; CSR: clinical study report; NA: not applicable; PM: published manuscript; RT: registered trial.