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Table 1 Inclusion and exclusion criteria for SU add-on systematic review
| Inclusion criteria | Description |
|---|---|
| Population | 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. |
| Treatment pathway | Add-on pharmacological therapy after failure of SU monotherapy, where the first-line SU was initiated because metformin was considered inappropriate. |
| Interventions | Pharmacological therapies that would be added to a SU in clinical practice when SU monotherapy does not provide adequate glycaemic control. |
| Comparators | 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]. |
| Outcomes | To be included in the meta-analysis, studies needed to report at least 1 of the primary endpoints of interest at 24 +/- 6 weeks: |
| • mean change in HbA1c from baseline | |
| • mean change in weight from baseline | |
| • mean change in systolic blood pressure from baseline | |
| • proportion (number) of patients experiencing at least 1 hypoglycaemia episode | |
| Interim results from longer-term studies were permitted provided that dose titration and a sufficient maintenance period were complete at follow-up. | |
| Study design | • Prospective, RCTs. |
| • If cross-over design then results reported prior to the cross-over period can be used in the meta-analysis. | |
| • 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. | |
| Publications | Full-text publications, except for abstracts published in 2012 (for results from recently completed trials), full-text available in English. |
| Exclusions | • Results from uncontrolled open label extensions of RCTs. |
| • Studies of SU used as part of a triple therapy regimen. | |
| • Study populations with moderate to severe renal impairment. | |
| • Study arms using treatment dosing regimens that are not licensed in the EU. |
