| Study |
Bias |
| Randomisation process |
Deviations from intended interventions |
Missing outcome data |
Measurement of the outcome |
Selection of the reported results |
Overall |
| Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
Authors' judgement |
Support for judgement |
| Subgroup 5.3.1 Published |
| BEGIN Basal‐Bolus Type 1 |
Low risk of bias |
Participants were allocated to treatment with insulin degludec or insulin glargine in a 3:1 ratio. The Interactive Voice/Web Response System IV/WRS allocated the trial product to the participant at each dispensing and randomisation visit. There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. The statistical evaluation of the full analysis set (FAS) was to follow the intention‐to‐treat (ITT) principle and participants were to contribute to the evaluation “as randomised”. |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. The statistical evaluation of the FAS was to follow the intention‐to‐treat (ITT) principle and participants were to contribute to the evaluation “as randomised”. The safety analysis set included all participants who received at least one dose of the investigational product or its comparator. Only endpoints derived after 52 weeks of treatment were to be analysed statistically. Missing values were imputed by last‐observation‐carried‐forward (LOCF) for all endpoints. |
Some concerns |
Open‐label design. Outcome measure could have been influenced by knowledge of the intervention received. It it unlikely that there were strong beliefs in beneficial or harmful effects of the interventions. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Some concerns |
Open‐label design. Outcome measure could have been influenced by knowledge of the intervention received. It it unlikely that there were strong beliefs in beneficial or harmful effects of the interventions. |
| Subgroup 5.3.2 Unpublished |
| SWITCH 1 |
Low risk of bias |
Participants were randomised in a 1:1 manner to one of the two treatment sequences, using the Interactive Voice/Web Response System IV/WRS. Within each treatment sequence participants were randomised 1:1 to morning or evening dosing. There were no relevant baseline imbalances. |
Low risk of bias |
Double‐blind crossover study (participants, the clinical study group and the investigator remained blinded throughout the trial). Analyses of all endpoints were based on the full analysis set (FAS). Efficacy endpoints and patient‐reported outcome endpoints were summarised using the FAS. Safety endpoints were summarised using the safety analysis set. |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. The statistical evaluation of the full analysis set (FAS) was to follow the intention‐to‐treat (ITT) principle and participants were to contribute to the evaluation “as randomised”. The safety analysis set included all participants who received at least one dose of the investigational product or its comparator. Analyses of all endpoints were based on the FAS. Efficacy endpoints and patient‐reported outcome endpoints were summarised using the FAS. Safety endpoints were summarised using the SAS. |
Low risk of bias |
Double‐blind design (participants, the clinical study group and the investigator remained blinded throughout the trial). |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
