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Objectives To compare the benefits and harms of metformin and insulin versus insulin alone as reported in randomised clinical trials of patients with type 2 diabetes. Design Systematic review of randomised clinical trials with meta-analyses and trial sequential analyses.
Data sources The Cochrane Library, Medline, Embase, Science Citation Index Expanded, Latin American Caribbean Health Sciences Literature, and Cumulative Index to Nursing and Allied Health Literature until March 2011.
Review methods Two authors independently screened titles and abstracts for randomised clinical trials comparing metformin and insulin versus insulin alone (with or without placebo) in patients with type 2 diabetes, older than 18 years, and with an intervention period of at least 12 weeks.
Results We included 26 randomised trials with 2286 participants, of which 23 trials with 2117 participants could provide data.
Conclusions There was no evidence or even a trend towards improved all cause mortality or cardiovascular mortality with metformin and insulin, compared with insulin alone in type 2 diabetes. Previous meta-analyses of glucose lowering drugs have included trials of insulin in combination with various glucose lowering compounds such as metformin, but have not addressed the specific effect of metformin and insulin in this respect.11 12 13 In the light of these considerations and the growing number of patients with type 2 diabetes receiving insulin worldwide, we compared the benefits and harms of metformin and insulin versus insulin alone in randomised clinical trials.
We searched the Cochrane Library, Medline, Embase, Science Citation Index Expanded, Latin American Caribbean Health Sciences Literature, and Cumulative Index to Nursing and Allied Health Literature until March 2011 (web appendix). Two authors (BH and LLC or TA) independently screened titles and abstracts according to the inclusion criteria. We did statistical analysis using Review Manager16 according to our protocol.15 The medians reported in the included trials were assumed to be close to the arithmetic mean. We used both a random effects model and a fixed effect model.19 20 In case of discrepancy between the two models, we reported both results. We did subgroup analyses for primary and secondary outcomes if significant effect estimates were present using a test of interaction. The trial sequential analysis was done to maintain an overall 5% risk of a type I error and 20% of the type II error. Sixteen trials with 1627 participants reported all cause mortality, of which five reported 21 deaths (fig 2?).
Subgroup analysis according to insulin regimen used was not possible because the three trials with fixed insulin regimens in intervention groups reported no fatal events.48 49 50 We also could not analyse publication status because all the included trials were published.


Fifteen trials with 1498 participants reported on cardiovascular mortality, of which three trials reported six deaths (fig 2). The reporting of macrovascular and microvascular complications was infrequent, and all the outcomes assessed showed non-significant effect estimates (data not shown). Most trials reported hypoglycaemia data in a format that could not be included in a meta-analysis.3 6 29 36 38 40 43 47 48 Eleven trials with 1303 participants reported severe hypoglycaemia (fig 3?).
As the largest and longest trial, the HOME trial did not report the number of participants with serious hypoglycaemia at the end of the intervention period. We also searched abstracts presented at the American Diabetes Association and European Association for the Study of Diabetes Congresses, contacted relevant trial authors and pharmaceutical companies, hand searched reference lists of included trials, and searched the US Food and Drug Administration website. We included trials irrespective of language, publication status, predefined outcomes, antidiabetic interventions used before randomisation, and reported outcomes. Data were limited by the severe lack of data reported by trials for patient relevant outcomes and by poor bias control.
We also searched abstracts presented at the American Diabetes Association and European Association for the Study of Diabetes Congresses.
Randomised clinical trials were included if they compared metformin and insulin versus insulin alone (with or without placebo) in patients with type 2 diabetes older than 18 years, and had an intervention period of at least 12 weeks. Data extraction and assessment for all relevant non-English articles were obtained through translated texts.
If not reported, the standard deviation of the changes from baseline to the end of follow-up was calculated with a correlation coefficient from the largest and longest trial with all available data for each continuous variable in each intervention group.14 17 18 Reported standard errors and confidence intervals were converted to standard deviations.
We examined heterogeneity with the I2 statistic (I2 ?50% indicated substantial heterogeneity).14 To clarify the influence of missing data, we conducted scenario analyses for the “worst best” case and “best worst” case for the primary outcomes. On the basis of criteria decided a priori, we calculated the required information size (adjusted for diversity) to detect or reject an intervention effect of a 10% relative risk reduction, considered as a clinically relevant effect corresponding to a numbers needed to treat of about 200.21 22 23 24 25 28 However, if the required information size was very large, we also performed post hoc trial sequential analysis, with a 30% relative risk reduction. We extracted data but did not report data for cancer, fasting blood glucose, and blood pressure. One trial was only published as abstracts,29 32 33 one in a single abstract,31 and one in a letter.34 All trial authors were contacted, but only a few provided additional data. The total daily dose of metformin in the intervention groups varied between 1000 mg and 2550 mg.


For this study,44 we reported the two types of insulin preparations in combination with metformin or placebo separately: neutral protamine Hagedorn insulin in combination with metformin or placebo (SDDSa), and insulin aspart in combination with metformin or placebo (SDDSb). Only three trials reported severe hypoglycaemia in 24 patients (metformin and insulin, 18; placebo and insulin, six). We contacted relevant pharmaceutical companies, and searched the US Food and Drug Administration website for unpublished randomised trials relevant to the review. When the estimated required information size (to show or refute a 10% relative risk reduction) was very large, we did a trial sequential analysis for a 30% relative risk reduction. We included two crossover trials, and the authors were unable to provide data before the crossover.30 35 Tables 1 and 2? ? show baseline characteristics of the included trials.
Trial sequential analysis indicated that only 2.93% of the required information size was accrued to detect or reject a 30% reduction in relative risk. Trial sequential analysis indicated that only 0.65% of the required information size was accrued to detect or reject a 30% reduction in relative risk.
We also scanned reference lists of included trials and systematic reviews, meta-analyses, and health technology assessment reports. We excluded intervention groups including concomitant use of glucose lowering drugs other than metformin or insulin. Thirty publications describing 26 randomised clinical trials met our inclusion criteria, randomly assigning 2286 patients to metformin and insulin versus to insulin alone. Trial sequential analyses showed that more trials were needed before reliable conclusions could be drawn regarding these outcomes. Three trials could not provide data for the meta-analysis because they only described the total number of patients who underwent randomisation.29 30 Accordingly, 23 trials (2117 participants) provided data for our analyses.



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