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. 2023 Mar 28;2023(3):CD006127. doi: 10.1002/14651858.CD006127.pub3

6. Design features of trials for hypertensive type 2 diabetic participants, by date trial initiated or earliest publication.

Characteristic UKPDS/HDS ABCD (2) Steno‐2 Rachmani 2002 ADDITION‐Europe ADVANCE/AdRem DEMAND BENEDICT HINTS J‐DOIT3
Year trial initiated 1987 1991 1992 1995 2001 2002 2002 2003a 2006 2006
Definition of "hypertension",
SBP/DBP, mmHg, or otherb
≥ 160/95 or antihypertensive medication DBP ≥ 90 ≥ 160/95
(≥ 135/85)
> 140/90 or antihypertensive medication > 135/85 > 140/90 or
antihypertensive medication ≥ 130/85 or antihypertensive medication na > 140/90 or antihypertensive medication > 130/80
Primary outcome, parent study Macro‐ and microvascular complications 24‐hour creatinine clearance Nephropathy eGFR Death, CVD events Macro‐ and microvascular complications GFR Microalbuminuria BP control Macrovascular
diabetic complications
Type of intervention:
More BP control ACEi or
β blocker
ACEi or CCA Intensive
intervention
Patient participation in education and care  Stepped antihypertensive medication ACEi or 
diuretic ACEi or CCB ACEi, ndCCB, or combination Nurse
management
"Intensive intervention"
Less BP control No ACEi or
β blocker
Placebo Conventional treatment Standard care Routine care Placebo CCB or placebo Placebo Usual care Conventional intervention
Blood pressure target:
More BP control < 150/85 mmHg DBP < 75 mmHg < 140/85
(< 130/80c)
< 130/85 mmHg ≤ 120/80 mmHg na < 120/80 mmHg < 120/80 mmHg ≤ 140/80 mmHg ≤ 120/75 mmHg
Less BP control < 180/105 mmHg DBP 80 to 89 mmHg < 160/95
(< 135/85c)
na ≤ 135/85 mmHg na < 120/80 mmHg < 120/80 mmHg ≤ 140/80 mmHg ≤ 130/80 mmHg
Other randomized intervention(s) Intense glucose control vs standard None None None Intense glucose and cholesterol control vs standard Intense glucose control vs standard None ndCCB vs placebo None None
Method of DR diagnosis Photos graded centrally. Photos graded centrally.d Photos graded centrally.e Fundus exams Photos graded
centrally.e
Photos graded centrally.f Fundus exams + photos Fundus exams + photos Diagnosis in electronic chart  Fundus exams + records

aDate of earliest publication.
bAs defined by investigators.
cFrom 2000.
dWisconsin Fundus Photograph Reading Center.
eBaseline photos taken up to 3 months before/after randomization.
fAdRem Sub‐study Coordination Centre, Utrecht, the Netherlands.
 

ACEi, angiotensin converting enzyme inhibitor
BP, blood pressure (systolic/diastolic) or other
CCA, calcium channel antagonist
CCB, calcium channel blocker
CVD, cardiovascular disease
DBP, diastolic blood pressure, mmHg
DR, diabetic retinopathy
eGFR, estimated glomerular filtration rate
GFR, glomerular filtration rate
na, information not found in study publications
ndCCBs, non‐dihydropyridine calcium channel blockers
SBP, systolic blood pressure, mmHg