Onuchin 2010.
| Study characteristics | ||
| Methods | Study design: parallel RCT | |
| Participants |
Inclusion criteria: female, age above 55 years, duration of T2DM > 3 years, inadequately controlled for more than a year, abdominal obesity, arterial hypertension Exclusion criteria: thyroid disease, AMI during study, chronic obstructive pulmonary disease, liver cirrhosis Diagnostic criteria: WHO 1999 |
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| Interventions |
Intervention(s): metformin Comparator(s)1: insulin Duration of intervention: 12 months Duration of follow‐up: 12 months Run‐in period: none Number of study centres: not reported |
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| Outcomes | Reported outcome(s) in full text of publication: glycaemic variables, anthropometric measures, health‐related quality of life, lipid profile, albuminuria, blood pressure, cardiac function, risk of developing cardiac adverse events, depression | |
| Study details |
Trial identifier: not reported Trial terminated early: no |
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| Publication details |
Language of publication: Russian Funding: not reported Publication status: full article |
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| Stated aim for study | Quote from publication: "[The aim of the study was a comparative evaluation of the efficacy of various variants of glucose‐lowering drugs in patients with type 2 diabetes mellitus inadequately controlled for more than 1 year]" | |
| Notes | 1There were 2 more comparators that were not of interest to this review | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote from publication: "[Patients were randomised by random number method]..." Comment: method of random sequence generation inadequately described |
| Allocation concealment (selection bias) | Unclear risk |
Quote from publication: "[Patients were randomised by random number method]..." Comment: method of allocation concealment inadequately described |
| Blinding of participants and personnel (performance bias) health‐related quality of life | High risk |
Quote from publication: "[An open prospective study]... " Comment: self‐reported outcome measurement. No blinding and outcome judged likely to be influenced by a lack of blinding. |
| Blinding of outcome assessment (detection bias) health‐related quality of life | High risk |
Quote from publication: "[An open prospective study]... " Comment: self‐reported outcome measurement. No blinding and outcome judged likely to be influenced by a lack of blinding. |
| Incomplete outcome data (attrition bias) health‐related quality of life | Unclear risk | Comment: 100% of participants included in the analysis, however, dropout rate not reported and unclear whether there were missing data and how they were handled |
| Selective reporting (reporting bias) | High risk | Comment: study protocol not available. Clear that all‐cause mortality and serious adverse events were measured but were not necessarily analysed; judgement says likely to have been analysed but not reported because of non‐significant results. Unclear whether severe hypoglycaemia was measured, since hypoglycaemia was reported in the trial; not mentioned, but clinical judgement says likely to have been measured and analysed but not reported on the basis of non‐significant results |
| Other bias | Unclear risk | Comment: funding source not reported |