Rosenstock 2006b.

Methods	DURATION OF INTERVENTION: 24 weeks DURATION OF FOLLOW‐UP: 24 weeks RUN‐IN PERIOD: during the screening/titration phase, patients not on the maximum metformin dose were titrated to 2000 mg/day; patients on 1000 mg/day increased their dose to 1500 mg/day immediately and to 2000 mg/day 1 week later (or maximum tolerated dose), followed by a 2‐week stabilization period; patients on 1500 mg/ day increased their dose to 2000 mg/day immediately followed by a 2‐week stabilization period LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: insulin‐naive patients with type 2 diabetes inadequately controlled on dual oral therapy with sulfonylurea plus metformin INCLUSION CRITERIA: participants >= 18 years of age with type 2 diabetes (HbA1c >= 7.5 and <= 11%) and a BMI of > 25; continuous oral hypoglycemic treatment using stable daily doses of >= 50% of the maximally labeled dose of a sulfonylurea and at least 1000 mg metformin was required for >= 3 months before the screening visit EXCLUSION CRITERIA: stroke, myocardial infarction, angina pectoris, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the previous 12 months; history of congestive heart failure; treatment with nonselective beta‐blockers; hypoglycemia unawareness; impaired renal function; active liver disease; substance or alcohol abuse; malignancy; planned radiological examinations requiring administration of contrasting agents DIAGNOSTIC CRITERIA: HbA1c >= 7.5 and <= 11% CO‐MORBIDITIES: not stated CO‐MEDICATIONS: not stated
Interventions	NUMBER OF STUDY CENTRES: 42 COUNTRY/ LOCATION: USA SETTING: not stated INTERVENTION (DOSE/DAY): >= 50% of maximal‐dose sulfonylurea and metformin + rosiglitazone 4 mg/day (mean daily dose rosiglitazone was 7.1 +‐ 1.7 mg) CONTROL (DOSE/DAY): >= 50% of maximal‐dose sulfonylurea and metformin + insulin glargine 10 units/day (mean daily dose of insulin glargine was 38.5 +‐ 26.5 IU) TREATMENT BEFORE STUDY: slfonylurea and metformin doses remained unchanged during the treatment phase of the study TITRATION PERIOD: (see run‐in phase) all patients randomized to insulin glargine received a single daily subcutaneous injection at bedtime at a starting dose of 10 IU/day for 7days, the dose was titrated weekly according to self‐monitored FPG, supervised centrally to ensure compliance, to meet target FPG <100 –120 mg/dl (<5.5– 6.7 mmol/L) all patients randomized to treatment with rosiglitazone received a starting oral dose of 4 mg once daily for 6 weeks; if the FPG value was >100 mg/dl (>5.5 mmol/L) after 6 weeks, rosiglitazone was increased to a maximum of 8 mg/day
Outcomes	PRIMARY OUTCOMES: not stated (HbA1c differences between therapies) SECONDARY OUTCOMES: (not stated) assessment of hypoglycaemia profile; changes in FPG, body weight, and serum lipids; proportion of patients achieving HbAA1C <= 7%; cost of therapy safety was assessed in the intent to treat (ITT) population through adverse events, hypoglycaemia, body weight, physical examinations, vital signs, standard hematology,and blood chemistry a physical examination to identify signs of peripheral oedema was performed at baseline and final visit or at patient discontinuation Cost analysis: The economic costs of glyceemic control were compared by combining selected measures of resource use with unit‐cost estimates. Resource measures included study medication, other antihyperglycaemic agents, syringes for insulin glargine, glucose testing supplies for both groups, and recommended liver function tests for the rosiglitazone group. Resource use was based on trial data over the 24‐week period. Costs of medications, insulin syringes, test strips, and lancets were estimated using average wholesale prices expressed in 2002 U.S. dollars and were based on the numbers actually dispensed. The cost of hepatic function panels was estimated using fee schedules under Medicare’s Resource‐Based Relative Value Scale. Economic costs were summarized using means and 95% CIs and calculated through techniques of bootstrapping. Results were not adjusted for differences between treatment
Notes	AIM OF STUDY: to evaluate the efficacy and safety of insulin glargine or rosiglitazone as add‐on therapy in patients with type 2 diabetes with chronic hyperglycemic control despite maximized combination therapy with metformin plus a sulfonylurea
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear