Table 1.
Characteristics of Randomized, Controlled Trials of Intensive Glucose Control
| CHARACTERISTIC | Kumamoto4 | UKPDS 3314 | UKPDS 3415 | VA Diabetes Feasibility Trial5 |
ACCORD7 | ADVANCE11 | VADT10 |
|---|---|---|---|---|---|---|---|
| Year of Publication | 1995 | 1998 | 1998 | 2000 | 2008 | 2008 | 2009 |
| Participants, n | 110 | 3867 | 753 | 153 | 10,251 | 11,140 | 1791 |
| Country | Japan | UK | UK | USA | USA & Canada | Multi-national | USA |
| Median Year of Enrollment | 1991 | 1984 | 1984 | 1991 | 2003 | 2002 | 2002 |
| Age (mean, yrs) | 49 | 53.3 | 53 | 60.1 | 62.2 | 66 | 60.4 |
| Race-ethnicity (%) | |||||||
| Non-Hispanic white | 0 | 81 | 85 | … | 64 | … | 62 |
| Hispanic white | 0 | … | … | … | 7 | … | 16 |
| Black | 0 | 8 | 10 | … | 19 | … | 17 |
| Asian | 100 | 10 | 4 | … | … | … | … |
| Mean duration of diabetes (years) | 6.5/10.2 | 0 | 0 | 8 | 10 | 8 | 12 |
| Men (%) | 45 | 61 | 46 | 100 | 61 | 58 | 97 |
| Current Smokers (%) | … | 31 | 39 | 26 | 14 | 14 | 17 |
| Hypertension (%) | … | 12 | 16 | … | 85 | … | 72 |
| Hx of CVD (%) | … | … | … | 13 | 35 | 32 | 40 |
| SBP (mm Hg) | 120/122 | 135 | 140 | 135 | 136 | 145 | 132 |
| DBP (mm Hg) | 70/70 | 82 | 85 | 81 | 75 | 80 | 76 |
| Mean LDL (mmol/L) | 2.7 | 3.5 | 3.7 | … | 2.7 | 3.1 | 2.8 |
| Body weight (kg) | … | 77.5 | 87 | … | 94 | 78 | 97 |
| BMI (kg/sq meter) | 21.4/19.3 | 27.5 | 31.6 | 31 | 32.2 | 28 | 31.3 |
| HbA1C (%) | 9.1/9.2 | 7 | 7.3 | 9.7 | 8.3 | 7.2 | 9.4 |
| Creatinine (µmol/L) | … | 81 | 77 | 83 | 80 | 87 | 88.4 |
| Macroalbuminuria (%) | 0 | 1.6% | 2% | … | 6 | 3.6 | … |
| Microalbuminuria (%) | 0 | 10.5% | < 7.6% | 38 | 27 | 25.6 | … |
| Urine Alb:creat | 13/43 | … | … | 0.042 | 1.54 | … | … |
| Fasting plasma glucose (mmol/L) | … | 8 | 8.1 | 11 | 9.3 | 7.9 | … |
| GFR (ml/min) | … | … | … | … | 90 | … | … |
| ARB/ACEI (%) | … | … | … | 37 | 53 | … | … |
| Statins (%) | … | … | … | … | 62 | 28 | … |
| Target HbA1C% in intensive glucose group | <7% | FPG < 6 mmol/L | FPG < 6 mmol/L | 5% | <6% | ≤6.5% | < 6% and 1.5% less than conventional |
| Target HbA1C% in conventional glucose group | …* | FPG 6.1–15 mmol/L | FPG 6.1–15 mmol/L | Avoidance of excessive hyperglycemia | 7–7.9% | Local standards | < 9% and 1.5% higher than intensive |
| Primary agent in intensive arm | Insulin | Sulfonylurea or insulin | Metformin plus sulfonylurea | Insulin | Multiple Drugs | Gliclazide | BMI ≥ 27: metformin & rosiglitazone BMI < 27: glimerpiride & rosiglitazone |
| Median duration of treatment (years) | 6 | 11.1 | 10.7 | 2 | 3.7 | 5 | 5.6 |
| Median follow-up (years) | 8 | 11.1 | 10.7 | 2 | 5 | 5.0 | 5.6 |
2 separate numbers reported for primary prevention arm (n=55 in each); The clinical and glycemic goals for the intensive therapy group in the Kumomato study was to maintain the blood glucose control as close to the fasting blood glucose concentration of < 140 mg/dL, 2 hour post-prandial blood glucose concentration < 200 mg/dL, HbA1C < 7.0% and mean amplitude of glycemic excursions < 100 mg/dL. The goals in the conventional arm was to show no symptoms of hyperglycemia or hypoglycemia, and glycemic control as close to the fasting glucose concentration of < 140 mg/dL.
…= Not Reported
Abbreviations: CAD- coronary artery disease, SBP- systolic blood pressure, DBP- diastolic blood pressure, LDL- low density lipoprotein, BMI- body mass index, GFR- glomerular filtration rate, ARB- angiotensin receptor blocker, ACEI- angiotensin converting enzyme inhibitor; FPG- fasting plasma glucose.