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Population
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Adults (aged ≥18 years) with T2DM on a stable dose of a SU as monotherapy (for at least 8 weeks, at half the maximum dose or maximum tolerable dose) where SU alone, with diet and exercise, does not provide adequate glycaemic control.
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Treatment pathway
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Add-on pharmacological therapy after failure of SU monotherapy, where the first-line SU was initiated because metformin was considered inappropriate.
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Interventions
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Pharmacological therapies that would be added to a SU in clinical practice when SU monotherapy does not provide adequate glycaemic control.
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Comparators
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Active arms: Dual therapies of interest namely drugs/doses licensed in the EU, as a dual therapy in combination with a SU and as used in clinical practice[13].
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Outcomes
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To be included in the meta-analysis, studies needed to report at least 1 of the primary endpoints of interest at 24 +/- 6 weeks:
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• mean change in HbA1c from baseline
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• mean change in weight from baseline
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• mean change in systolic blood pressure from baseline
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• proportion (number) of patients experiencing at least 1 hypoglycaemia episode
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Interim results from longer-term studies were permitted provided that dose titration and a sufficient maintenance period were complete at follow-up.
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Study design
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• Prospective, RCTs.
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• If cross-over design then results reported prior to the cross-over period can be used in the meta-analysis.
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• Minimum follow-up of 18 weeks to be included in the meta-analysis (i.e. 24 weeks +/-6 weeks); an expansion of the study window to 24 +/- 8 weeks as a sensitivity analysis for borderline studies was permitted.
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Publications
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Full-text publications, except for abstracts published in 2012 (for results from recently completed trials), full-text available in English.
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Exclusions
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• Results from uncontrolled open label extensions of RCTs.
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• Studies of SU used as part of a triple therapy regimen.
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• Study populations with moderate to severe renal impairment.
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• Study arms using treatment dosing regimens that are not licensed in the EU.
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