NCT01650129

Methods	Parallel randomised controlled trial, randomisation ratio 2:1
Participants	Inclusion criteria: age ≥ 20 years; diagnosed with T2DM; treated with insulin ≥ 24 weeks and on current treatment with premixed biphasic human insulin preparation (rapid acting/intermediate acting (NPH) = 5:5) in a twice daily regimen (before breakfast and dinner) ≥ 12 weeks; HbA1c ≤ 11.0 %; BMI < 30.0 kg/m² Exclusion criteria: not reported Diagnostic criteria: T2DM according to Japanese Diabetes Society classification
Interventions	Number of study centres: 14 Treatment before study: treatment with insulin ≥ 24 weeks, treatment with premixed biphasic human insulin preparation in twice daily regimen ≥ 12 weeks Titration period: 24 weeks
Outcomes	Outcomes reported in abstract of publication: adverse events; incidence of hypoglycaemic episodes; insulin antibodies; HbA1c; blood glucose control parameters; safety profile through laboratory tests (haematology and biochemistry)
Study details	Run‐in period: not reported Study terminated early: no Trial register ID:NCT01650129
Publication details	Language of publication: English Funding: commercial (Novo Nordisk) Publication status: other (NovoNordisk Clinical Trial report BIAsp‐1352)
Study aim for study	Quote from publication: "Primary objective was to: Investigate the safety profile of NN‐X14Mix50 as measured by the occurrence of adverse events during 24 weeks of treatment compared to BHI50"
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "A total of 75 subjects were planned to be randomised" Comment: not enough details
Allocation concealment (selection bias)	Unclear risk	Comment: not reported
Blinding of participants and personnel (performance bias) All‐cause mortality	Low risk	Quote from study report: "open‐labelled" Comment: outcome measure unlikely to be influenced by lack of blinding
Blinding of participants and personnel (performance bias) Severe hypoglycaemia	High risk	Quote from study report: "open‐labelled" Comment: outcome measure likely influenced by lack of blinding
Blinding of participants and personnel (performance bias) HbA1c	Unclear risk	Quote from study report: "open‐labelled" Comment: laboratory measure, not clear if measured centrally
Blinding of participants and personnel (performance bias) Adverse events	High risk	Quote from study report: "open‐labelled" Comment: outcome measure likely influenced by lack of blinding
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Quote from study report: "open‐labelled" Comment: outcome measure unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Severe hypoglycaemia	High risk	Quote from study report: "open‐labelled" Comment: outcome measure likely influenced by lack of blinding
Blinding of outcome assessment (detection bias) HbA1c	Unclear risk	Quote from study report: "open‐labelled" Comment: laboratory measure, not clear if measured centrally
Blinding of outcome assessment (detection bias) Adverse events	High risk	Quote from study report: "open‐labelled" Comment: outcome measure likely influenced by lack of blinding
Incomplete outcome data (attrition bias) All‐cause mortality	Low risk	Comment: proportion of participants included in analyses adequate. Missing data balanced across intervention groups
Incomplete outcome data (attrition bias) Severe hypoglycaemia	Low risk	Comment: proportion of participants included in analyses adequate. Missing data balanced across intervention groups
Incomplete outcome data (attrition bias) HbA1c	Low risk	Comment: proportion of participants included in analyses adequate. Missing data balanced across intervention groups
Incomplete outcome data (attrition bias) Adverse events	Low risk	Comment: proportion of participants included in analyses adequate. Missing data balanced across intervention groups
Selective reporting (reporting bias)	Unclear risk	Comment: for several outcomes, the results were not reported in detail, trial authors only reported that no significant difference was found
Other bias	Low risk	Comment: none detected