RIO‐Diabetes.

Methods	DURATION OF INTERVENTION: 12 months DURATION OF FOLLOW‐UP: 0 months RUN‐IN PERIOD: 1‐ ? LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: INCLUSION CRITERIA: Age: 18 to 70 years old; BMI of 27 to 40 kg/m2; type 2 diabetes that had been treated with metformin or various sulfonylurea monotherapy for at least 6 months. hgA1c between 6.5% and 10%, fasting plasma glucose between 100 mg/dL and 271 mg/dL, variation in body weight within the previous three months < 5kg EXCLUSION CRITERIA: ?
Interventions	NUMBER OF STUDY CENTRES: 151 COUNTRY/LOCATION: USA and 10 other countries (?) SETTING: ? INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Placebo or rimonabant 20 mg or rimonabant 5 mg ‐ daily in addition to a hypocaloric diet
Outcomes	PRIMARY: weight change in 1 year SECONDARY: change in hgA1c, waist circumference, fasting lipid levels with emphasis on HDL and TG, and change in metabolic syndrome prevalence as defined by the ATP III criteria. TIMING OF OUTCOME MEASURES: body weigh, BP, waist circumference ‐ monthly, the other measures every 3 months ALL‐CAUSE MORTALITY. 0 DISEASE SPECIFIC MORTALITY: 0 MORBIDITY/COMPLICATIONS: 1 QUALITY OF LIFE: 0 ADVERSE EFFECTS: 1 COSTS: 0
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear