Table 8.

Characteristics of studies awaiting assessment [ordered by study ID]

ABCD-2V
Methods	Study design: randomized controlled trial, single center Unit of randomization and analysis: individual Number randomized - Total: 129 Per group: 66 allocated to intensive treatment; 63 allocated to moderate treatment Sample size calculation: not reported
Participants	Country: USA Study period: not reported Age: mean (SD) 56.7 (7.7) years in intensive treatment group and 55.5 (7.7) in moderate treatment group Gender: 33.3% in intensive treatment group and 31.7% in moderate treatment group were women Race/ethnicity: 71.2% white, 19.7% Hispanic, 9.1%African-American in intensive treatment group; 76.2% white, 11.1% Hispanic, 6.4% African-American, and 3.2% Asian in moderate treatment group Inclusion criteria: type 2 diabetes, 40 to 81 years of age, with a SBP < 140 mmHg, a DBP between 80 and 90 mmHg, and without evidence of overt albuminuria (< 200 μg/min) Exclusion criteria: “pregnant or lactating women, need for any antihypertensive medications, documented myocardial infarction or cerebrovascular accident within the past 6 months, severe peripheral vascular disease, history of bilateral renal artery stenosis or stenosis in a solitary kidney, evidence of severe liver disease, hyperkalemia, or history of active cancer” Type of diabetes: type 2 HbA1c categories/levels: not reported Retinopathy status: both non-proliferative and proliferative
Interventions	Intervention 1: intensive treatment Intervention 2: moderate treatment Length of follow-up: Planned: 5 years Actual: mean follow-up was 1.9 ± 1.0 years; ranging from < 1 year to 4 years, with 12 participants having 4 years of follow-up
Outcomes	Primary outcomes for this review: progression of diabetic retinopathy Secondary outcomes for this review: none mentioned Other diabetic retinopathy outcomes: regression of diabetic retinopathy Other outcomes: change in creatinine clearance from baseline, proportion with doubling of serum creatinine, and change in log urinary albumin excretion from baseline; progression/regression of neuropathy; incidence of cardiovascular events Intervals at which outcomes were assessed: every 6 months Eyes examined for outcome: not reported Cost of interventions: not reported Quality of life: not reported
Notes	Source of funding: Novartis Pharmaceutical Company Declaration of interest: not reported
ADDITION 2014
Methods	Study design: cluster randomized controlled trial Unit of randomization and analysis: individual Number randomized - Total: 3057 Per group: 1678 allocated to intensive care; 1379 allocated to routine care Sample size calculation: Yes; “We calculated that a patient-level randomised trial would have required enrolment of 2700 individuals (1350 per treatment group) to detect a 30% reduction in the risk of the primary endpoint at a 5% significance level, and with 90% power. This calculation allowed for 10% loss to follow-up and assumed an event rate in the routine care group of 3% per year, on the basis of the results of the UK Prospective Diabetes Study Group (UKPDS). We expected a minimum effect of clustering within general practice, with the estimated within-cluster correlation coefficient being 0·01. We assumed that the average number of participants per general practice would be 10 and, therefore, the design effect was 1·09. Thus, we inflated the estimated sample size for this cluster trial to 3000 patients in total.”
Participants	Country: Denmark, United Kingdom, the Netherlands Study period: September 2008 to the end of December 2009 Age: not reported Gender: not reported Race/ethnicity: not reported Inclusion criteria: newly diagnosed type 2 diabetes Exclusion criteria: patients had “contraindications to the proposed study medication, an illness with a life expectancy of 12 months, or psychological or psychiatric problems that were likely to invalidate informed consent” Type of diabetes: type 2 HbA1c categories/levels: not reported Retinopathy status: not reported
Interventions	Intervention 1: intensive treatment Intervention 2: routine care Length of follow-up: Planned: 5 years Actual: mean (SD) follow-up period of 5.3 (1.6) years
Outcomes	Primary outcomes for this review: combined incidence and progression of diabetic retinopathy Secondary outcomes for this review: none mentioned Other outcomes: neuropathy Intervals at which outcomes were assessed: not reported Eyes examined for outcome: both eyes, but whether average of two eyes were analyzed or whether two eyes were analyzed separately not stated Cost of interventions: not reported Quality of life: not reported
Notes	Source of funding: multiple sources from government agencies, foundations, etc Declaration of interest: multiple sources including receiving grants, speaking and travel expenses, advisory board members, etc Author’s contact information: Annelli Sandbæk, annelli.sandbaek@alm.au.dk
ROADMAP
Methods	Study design: randomized, double-blind, placebo-controlled, parallel-group, multicenter, phase III Unit of randomization and analysis: individual Number randomized - Total: not reported Per group: not reported Sample size calculation: Yes; The study can “detect a 30% reduction in the risk of microalbuminuria (hazard ratio of 1.433) with 90% power at the 5% significance level … Thus, at least 2043 subjects are needed in each treatment arm and 328 events of microalbuminuria are expected to be observed. To compensate for withdrawals, 2200 patients are being recruited and randomized to each of the two treatment arms of the study.”
Participants	Country: European countries including Austria, Belgium, Bulgaria, Czech Republic, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Russia, Slovak Republic, Spain, the Netherlands, the United Kingdom, and Ukraine Study period: not reported Age: not reported Gender: not reported Race/ethnicity: not reported Inclusion criteria: Type 2 diabetics free of signs of urinary albumin excretion who have one additional cardiovascular risk factor; if hypertensive, not taking ACE inhibitors or ARBs; 18 to 75 years of age; HbA1c ≥ 6.5% or are on treatment; hypertensive (SBP ≥ 130 mmHg and/or DBP ≥ 80 mmHg) Exclusion criteria: renal and/or renal-vascular disease (including malignant or severe renal disease); a history of nephrectomy and/or renal transplantation, or if they require dialysis; a recent history (within 6 months of starting the study) of myocardial infarction, stroke, transient ischaemic attack, myocardial revascularization or reperfusion; recent use of (within 6 months of starting the study) ARBs or ACE inhibitors or if they have severe hypertension, defined as SBP > 200 mmHg and/or DBP > 110 mmHg; severe uncontrolled hyperlipidaemia, severe heart failure, bradycardia (< 50 beats/minute at rest), a significant narrowing of the aortic bicuspid valve, a severe obstruction of cardiac outflow (hypertrophic cardiomyopathy, New York Heart Association (NYHA) stage 3–4) Type of diabetes: type 2 HbA1c categories/levels: not reported Retinopathy status: not reported
Interventions	Intervention 1: 40 mg olmesartan twice daily with water before breakfast Intervention 2: placebo tablet twice daily with water before breakfast Length of follow-up: Planned: 5 years Actual: not reported
Outcomes	Primary outcome for this review: incidence and progression of retinopathy Secondary outcomes for this review: none mentioned Other outcomes: time to albuminuria, cardiovascular mortality, stroke, cardiovascular morbidity, serum creatinine, hospitalization for various bad outcomes (end-stage renal disease, worsening glomerular filtration rate) Intervals at which outcomes were assessed: week 4, week 12, and month 6 (visits 2, 3, and 4, respectively) and thereafter every 6 months until the end of the study Eyes examined for outcome: not reported Cost of interventions: not reported Quality of life: not reported
Notes	Source of funding: Sankyo Declaration of interest: “All steering committee members are consultants for Sankyo for the ROADMAP study.”