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. |