Nemoto 2011.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
|
| Participants |
Inclusion criteria: people with type 2 diabetes on insulin therapy alone, HbA1c ≥ 6.5%, outpatients, age at least 20 years Exclusion criteria: not stated Diagnostic criteria: plasma glucose level at either 1 or 2 h after meal was 180 mg/dL or higher; HbA1c ≥ 6.5% |
|
| Interventions |
Number of study centres: not stated Treatment before study: insulin monotherapy (U/day (SD)): 31.7 (17.6) Titration period: 4‐10 weeks observation period |
|
| Outcomes |
Primary outcome(s) (as stated in the publication): meal tolerance test, plasma glucose AUC Secondary outcomes (as stated in the publication): HbA1c, 1,5 AG, glycoalbumin, hypoglycaemic symptoms ADDITIONAL OUTCOMES: safety |
|
| Study details |
Total study duration: 16‐22 weeks (4‐10 weeks observation + 12 weeks treatment) Run‐in period: 4‐10 weeks Study terminated early (for benefit/because of adverse events): no |
|
| Publication details |
Language of publication: English Funding source: Sanwa Kagaku Kenkyusyo Co Ltd Publication status: peer‐reviewed journal |
|
| Stated aim of study | Quote from publication: "To investigate the efficacy of combination therapy with miglitol and insulin" in people with type 2 diabetes receiving insulin therapy | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote from publication: "The enrolled patients were randomised to groups treated with miglitol or with placebo" 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 | Low risk |
Quote from publication: "We conducted a placebo‐controlled double‐blind comparative study..." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Unclear risk |
Quote from publication: "We conducted a placebo‐controlled double‐blind comparative study..." Comment: probably the participants and the personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Unclear risk |
Quote from publication: "We conducted a placebo‐controlled double‐blind comparative study..." Comment: probably the participants and the personnel were blinded |
| Blinding of outcome assessment (detection bias) Adverse events | Unclear risk | Comment: unclear if the outcome assessor was blinded |
| Blinding of outcome assessment (detection bias) HbA1c, FPG, lipids | Unclear risk | Comment: unclear if the outcome assessor was blinded |
| Blinding of outcome assessment (detection bias) Insulin dose | Unclear risk | Comment: unclear if the outcome assessor was blinded |
| Incomplete outcome data (attrition bias) Adverse events | Low risk | Comment: adverse events were collected and reported |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | Low risk | Comment: data on HbA1c were collected and reported |
| Incomplete outcome data (attrition bias) Insulin dose | Unclear risk | Comment: part of the results only described in figures, not in numbers |
| Selective reporting (reporting bias) | Unclear risk | Comment: part of the results only described in figures, not in numbers |
| Other bias | Unclear risk | Comment: funding unclear, possibly commercial |