Hirsch 1999.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Superiority design |
|
| Participants |
Inclusion criteria: people with type 2 diabetes with less than optimal control on insulin therapy alone. Exclusion criteria: not stated Diagnostic criteria: not stated |
|
| Interventions |
Number of study centres: 1 Treatment before study: insulin: dose not stated Titration period: not stated |
|
| Outcomes | Primary outcome(s) (as stated in the publication): glycaemic control (HbA1c, FPG), bodyweight, blood pressure, insulin dose, fasting insulin levels, fasting C‐peptide, hypoglycaemia | |
| Study details |
Total study duration: 5 months Run‐in period: no Study terminated early (for benefit/because of adverse events): no |
|
| Publication details |
Language of publication: English Funding source: Bristol‐Myers‐Squibb Publication status: peer‐reviewed journal |
|
| Stated aim of study | Quote from publication: "To prospectively evaluate the efficacy of metformin added to insulin for patients with type 2 diabetes with less than optimal glycaemic control on insulin alone." | |
| Notes | Publication is a letter | |
| 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 | Low risk |
Quote from publication: "... a 5‐month single‐center prospective double‐blind placebo‐controlled study" Comment: probably the participants and personnel were blinded |
| Blinding of participants and personnel (performance bias) HbA1c, FPG, lipids | Low risk |
Quote from publication: "... a 5‐month single‐center prospective double‐blind placebo‐controlled study" Comment: probably the participants and personnel were blinded |
| Blinding of participants and personnel (performance bias) Insulin dose | Low risk |
Quote from publication: "... a 5‐month single‐center prospective double‐blind placebo‐controlled study" Comment: probably the participants and personnel were 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: data on adverse events were reported |
| Incomplete outcome data (attrition bias) HbA1c, FPG, lipids | Low risk | Comment: the outcome data were collected and reported |
| Incomplete outcome data (attrition bias) Insulin dose | Low risk | Comment: data on insulin dose were collected and reported |
| Selective reporting (reporting bias) | High risk | Comment: short report of the trial |
| Other bias | Unclear risk | Comment: funded by a pharmaceutical company |