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Table 1. Randomized Controlled Trials of Tight Glycemic Control

Study
(Quality)
Study
Years
Groups
(Patients)
Glycemic
Control
Renal
Failure
Severe Visual
Impairment
Myocardial
Infarction
Stroke Amputation All-Cause
Mortality
UGDP, 1971 (48);
1978 (49)
(fair)
8.75 Placebo:
n = 204
22.8% increase1 NR Acuity20/200 either eye
11.2%

11.4%
(NS)

Significant ECG abnormality
20%

17.6%
(NS)

NR 1.5% 26.3%
Insulin variable:
n = 198
13.5% decrease1 1.6%
(NS)
24.0%
(NS)
UKPDS 33, 1998 (10)
(good)
10 Conventional therapy:
n = 1,138
7.9%2 <1%

Vision too poor to drive
11%

11%
(NS)

16.3% 4.8% 1.6% 18.7%
Intensive therapy:
n = 2,729
7.0%2 <1%
(p=0.45)
14.2%
(p=0.052)
5.4%
(p=0.52)
1.0%
(p=0.099)
17.9%
(p=0.44)
UKPDS 34, 1998 (47)
(good)
10.7 Conventional therapy:
n = 411 (primarily diet)
8.0%2 <1%

Blind in one eye
3.2%


3.5%
(p=0.87)

17.8% 5.6% 2.2% 21.7%
Intensive therapy:
n = 342 (metformin)
7.4%2 <1%
(p=0.90)
11.4%
(p=0.001)
3.5%
(p=0.13)
1.8%
(p=0.57)
14.6%
(p=0.011)
Kumamoto, 1995 (55);
2000 (51) (fair)
8 Conventional therapy:
n = 50
9.4%2 NR NR

Major CVD event


1.3 events/100 p-y

0.6 events/100 p-y
(NS)

  NR
Intensive therapy:
n = 52
7.1%2  
VA CSDM, 1997 (52);
1996 (54);
1995 (56);
1999 (50);
2000 (57)
(fair)
2.25 Standard therapy:
n = 78
9.2%2 NR

Unilateral or bilateral visual impairment


9.0%

6.7%
(NS)

5.1% 2.6% 0 5.1%
Intensive therapy:
n = 75
7.1%2 6.7%
(NS)
6.7%
(NS)
1.3%
(NS)
6.7%
(NS)
Steno 2, 1999 (53)
(fair)
3.8 Standard therapy:
n = 80
9.0%2 0

Blind in one eye
9.0%

1.3%
(NS)

Nonfatal
5.1%
Nonfatal
10.2%
5.1% 2.6%
Intensive therapy:
n = 80
7.6%2 0 5.2%
(NS)
1.3%
(NS)
5.2%
(NS)
5.2%
(NS)

1 Change in fasting blood glucose from baseline
2 Median hemoglobin A1C

Notes: NR = Not reported, UGDP = University Group Diabetes Program, UKPDS = UK Prospective Diabetes Study Group, Steno 2 = Steno type 2 randomized study, VA CSDM = VA Cooperative Study on Glycemic Control and Complications in Type 2 Diabetes

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