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 |
Acuity ≤20/200 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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