Raskin 2004.

Methods	DURATION OF INTERVENTION: 24 weeks DURATION OF FOLLOW‐UP: 24 weeks RUN‐IN PERIOD: a screening visit was followed by a 2‐week washout period (previous diabetes medication discontinued) LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: type 2 diabetic patients who had shown treatment failure using sulphonylurea monotherapy or metformin monotherapy INCLUSION CRITERIA: type 2 diabetes for at least 12 months, with HbA1c values > 7.0% and <= 12% during previous monotherapy with sulphonylurea or metformin (at 50% or more of the maximal recommended dosages) for at least 3 months EXCLUSION CRITERIA: if being treated within the previous 3 months with any of the following agents: insulin, repaglinide, thiazolidinediones, alpha‐glucosidase inhibitors, or combination therapy with antidiabetic medications DIAGNOSTIC CRITERIA: not stated CO‐MORBIDITIES: not stated CO‐MEDICATIONS: not stated
Interventions	NUMBER OF STUDY CENTRES: not stated (multicentre) COUNTRY/ LOCATION: USA SETTING: not stated INTERVENTION (DOSE/DAY): I1: rosiglitazone 8.0 mg/day (mean final dose) I2: rosiglitazone 6.0 mg/day (mean final dose) + repaglinide 4.0 mg/day (mean final dose) CONTROL (DOSE/DAY): repaglinide 12 mg/day (mean final dose) TREATMENT BEFORE STUDY: previous monotherapy with sulphonylurea or metformin (at 50% or more of the maximal recommended dosages) for at least 3 months: previous SU/metformin (n/n/tot) ‐ I1: 30/32/62, I2: 81/46/127 , C: 40/23/63 TITRATION PERIOD: 12‐week dose‐adjustment period: repaglinide monotherapy was initiated at 0.5 mg per meal if HbA1c levels were <= 8%, and at 1 mg per meal for all other patients; the initial dosage of rosiglitazone monotherapy was 2 mg b.i.d.; repaglinide/rosiglitazone combination therapy was initiated at 0.5 mg or 1 mg repaglinide per meal (adjusted according to HbA1c as above), plus 2 mg rosiglitazone b.i.d. all patients in groups treated with repaglinide (monotherapy or combination) could have dosage adjusted up to a maximal dose of 4 mg per meal; the rosiglitazone dosage could be doubled in monotherapy or combination therapy groups at week 12, up to a maximum dose not to exceed 4 mg b.i.d.; the dose‐adjustment period was followed by 12 additional weeks of maintenance therapy
Outcomes	PRIMARY OUTCOMES: change in HbA1c values from baseline to the end of study treatment SECONDARY OUTCOMES: changes in FPG values; alanine aminotransferase (ALT); lipids; adverse events and reports of hypoglycemic episodes
Notes	AIM OF STUDY: to investigate the therapeutic effects of repaglinide combination therapy with rosiglitazone; the efficacy, safety, and tolerability of the combination were compared with those of monotherapy with either agent alone, in patients who had shown treatment failure using sulphonylurea monotherapy or metformin monotherapy
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear