Trial 20 Assessment Sheet
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Trial Info
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Week26/10/2015
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Study ID20
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Journal nameBMJ
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Trial Title
Liraglutide in people treated for type 2 diabetes with multiple daily insulin injections: randomised clinical trial (MDI Liraglutide trial)
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Trial Linkhttp://www.bmj.com/content/bmj/351/bmj.h5364.full.pdf
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Publication date28/10/2015
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Registry linkhttps://www.clinicaltrialsregister.eu/ctr-search/trial/2012-001941-42/SE
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Registry ID
EudraCT 2012-001941-42
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Protocol link, if availablehttps://drive.google.com/open?id=0B2r5CjEdwpx_RlF6UXJvMk9oWTQ
Note: last revised for publication 23/07/2014, trial commenced Feb 2013. Therefore, pre-specified outcomes here are taken from the trial registry entry, given above.
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Prespecified Primary OutcomeCorrectly reported in main trial results tables?Incorrectly reported in main trial results tablesNot reported in tables, but reported elswhere in paper?Not reported in journal publication
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Primary endpoint will be change in HbA1c from baseline to week 24.
Yes
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Total1TOTALS1
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Prespecified Secondary OutcomeCorrectly reported in main trial results tables?Incorrectly reported in main trial results tablesNot reported in tables, but reported elswhere in paper?Not reported in journal publication
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1Change in weight from baseline to week 24Yes
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2Change in fasting glucose from baseline to week 24Yes
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3Change in the standard deviation of CGM from the run-in period to week 23-24Yes
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Change in mean glucose levels on CGM from the run-in period to week 23-24
Yes
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Change in 1.5 hour postprandial glucose levels on capillary glucose measurements from the run-in period to week 23-24
Yes
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Change in the score of the DTSQs from baseline to week 24
Yes
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Score of the DTSQc at week 24
Yes
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Proportion of patients with HbA1c less than 8.0% (64 mmol/mol) at week 24
Yes
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Proportion of patients with HbA1c less than 7.5% (58 mmol/mol) at week 24
Yes
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Change in total insulin dose from baseline to week 24
Yes
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Proportion of patients with HbA1c less than 7.0% (53 mmol/mol) at week 24
Yes
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Change in blood pressure from baseline to week 24
Yes
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Frequency of non-severe documented symptomatic hypoglycaemia (plasma glucose [PG] less than 4.0 mmol/l) from baseline to week 24
Yes
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Frequency of asymptomatic non-severe hypoglycaemia (PG less than 4.0 mmol/l) from baseline to week 24
Yes
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Frequency of non-severe documented symptomatic hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24
Yes
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Frequency of asymptomatic non-severe hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24
Yes
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Frequency of severe hypoglycaemia from baseline to week 24
Yes
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Change in blood lipid levels from baseline to week 24
Yes
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Total18TOTALS18
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Non-prespecified outcome in publicationCorrectly reported as non-pre-specified in tables?Not reported
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Total0TOTALS
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Complications to trial and issues arising in free text
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They have broken up some of their categories into multiple subcategories. For HbA1c target, they have shown significance at three realistic levels rather than just one. For No. of hypoglycaemic episodes, they have shown no significant increase in episodes at 5 different severity levels.
Lipid levels are broken up into 4 categories, all not significantly improved (ie they haven't cherry-picked the one that showed most improvement), and blood pressure levels were significantly reduced in systole, but not diastole. Again, they could have chosen to report only Systolic BP.
I feel the addition of CGM mean and DTSQ total score trivial, and does not warrant a letter.
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