Coniff 1995.

Methods	Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design
Participants	Inclusion criteria: people with type 2 diabetes of at least 6 months, stable body weight, not receiving sulphonylurea for at least 2 months Exclusion criteria: not stated Diagnostic criteria: WHO 1985
Interventions	Number of study centres: multicentre, number of centres not mentioned, 4 centres are mentioned in the acknowledgements Treatment before study: insulin: 56.8 (SE3.4) IU/day (intervention), 62.2 (SE3.3) IU/day Titration period: 6 weeks
Outcomes	Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, glucose tolerance tests, fasting blood glucose), insulin requirements Secondary outcomes (as stated in the publication): lipids, hypoglycaemic episodes
Study details	Total study duration: 6 weeks pretreatment, 24 weeks double‐blind, 6 weeks follow‐up (discontinuation acarbose) Run‐in period: 6 weeks Study terminated early (for benefit/because of adverse events): no
Publication details	Language of publication: English Funding source: Miles pharmaceutical division Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To determine whether a forced titration of acarbose (from 50 to 300 mg three times daily) administered over a 24‐week period, in conjunction with diet and insulin therapy, improves glycaemic control and reduce daily insulin requirements in insulin‐requiring type II diabetes."
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not possible to judge whether the sequence generation was adequate
Allocation concealment (selection bias)	Unclear risk	Comment: not possible to judge whether the allocation to the intervention and control group was concealed
Blinding of participants and personnel (performance bias) Adverse events	Unclear risk	Quote from publication: (abstract and main text): "This double‐blind, randomised, multicenter, placebo‐controlled study..." (main text) "The double‐blind endpoint was defined as last visit observation for each patients" Comment: at all measurement occasions the efficacy and safety tests were assessed. However it is not clear whether the physician or the outcome assessor was blinded in addition to the participants
Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids	Unclear risk	Quote from publication: (abstract and main text): "This double‐blind, randomised, multicenter, placebo‐controlled study..." (main text)"The double‐blind endpoint was defined as last visit observation for each patients" Comment: at all measurement occasions the efficacy and safety tests were assessed. However it is not clear whether the physician or the outcome assessor was blinded in addition to the participants
Blinding of participants and personnel (performance bias) Insulin dose	Low risk	Comment: data are reported
Blinding of outcome assessment (detection bias) Adverse events	Unclear risk	Quote from publication: (abstract and main text): "This double‐blind, randomised, multicenter, placebo‐controlled study..." (main text) "The double‐blind endpoint was defined as last visit observation for each patient" Comment: at all measurement occasions the efficacy and safety tests were assessed. However it is not clear whether the physician or the outcome assessor was blinded in addition to the participants
Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids	Unclear risk	Quote from publication: (abstract and main text): "This double‐blind, randomised, multicenter, placebo‐controlled study..." (main text) "The double‐blind endpoint was defined as last visit observation for each patient" Comment: at all measurement occasions the efficacy and safety tests were assessed. However it is not clear whether the physician or the outcome assessor was blinded in addition to the participants
Blinding of outcome assessment (detection bias) Insulin dose	Unclear risk	Quote from publication: (abstract and main text): "This double‐blind, randomised, multicenter, placebo‐controlled study..." (main text)"The double‐blind endpoint was defined as last visit observation for each patients" Comment: at all measurement occasions the efficacy and safety tests were assessed. However it is not clear whether the physician or the outcome assessor was blinded in addition to the participants
Incomplete outcome data (attrition bias) Adverse events	Low risk	Quote from publication: "Most adverse events involved.....There were no significant differences between treatment groups in the incidence of adverse events related to other body systems "
Incomplete outcome data (attrition bias) HbA1c, FPG, lipids	Low risk	Comment: data were collected and reported
Incomplete outcome data (attrition bias) Insulin dose	Low risk	Comment: data were reported
Selective reporting (reporting bias)	High risk	Comment: serum lipids and SGOT and SGPT values were not reported
Other bias	Unclear risk	Comment: funded by a pharmaceutical company