Background
Methods
Study design
Patients
Data collection and quality assurance
Statistical analyses
Results
Baseline patient characteristics
Baseline characteristic | All subjects (n = 8,632*) | HbA1c ≤ 6.5% (n = 3,369) | HbA1c > 6.5% to ≤ 7.0% (n = 3,644) | HbA1c > 7.0% to ≤ 7.5% (n = 1,618) | P-values for the comparison of 3 groups |
---|---|---|---|---|---|
Age (years) | 65.0 (57.0-74.0) | 64.0 (55.0-73.0) | 67.0 (59.0-74.0) | 66.0 (58.0-75.0) | <0.0001 |
Age > 75 years (%) | 19.7 | 17.7 | 20.5 | 22.0 | <0.001 |
Female sex (%) | 45.6 | 46.2 | 45.5 | 44.4 | 0.47 |
BMI (kg/m2) | 31.2 ± 5.9 | 31.1 ± 5.9 | 31.3 ± 5.8 | 31.4 ± 6.0 | 0.38 |
BMI > 30 kg/m2 (%) | 52.0 | 51.3 | 52.1 | 53.1 | 0.47 |
Waist circumference (cm) | 107.6 ± 14.5 | 107.0 ± 15.0 | 108.0 ± 14.0 | 108.0 ± 14.7 | 0.50 |
Current smokers (%) | 11.8 | 11.4 | 12.0 | 11.9 | 0.73 |
Diabetes duration (months) | 67.9 (31.7-117.3) | 55.7 (24.8-100.6) | 75.1 (35.7-122.4) | 82.7 (40.4-131.8) | <0.0001 |
Fasting glucose (mmol/l) | 8.5 ± 2.8 | 7.8 ± 2.6 | 8.8 ± 2.6 | 9.7 ± 3.1 | <0.0001 |
Postprandial glucose (mmol/l) | 10.9 ± 3.4 | 10.0 ± 3.2 | 11.2 ± 3.3 | 12.1 ± 3.7 | <0.0001 |
HbA1c (%) | 7.8 ± 2.1 | 7.2 ± 1.3 | 8.0 ± 2.8 | 8.6 ± 1.5 | <0.0001 |
≤6.5% (%) | 14.7 | 28.9 | 7.1 | 2.0 | <0.0001 |
>6.5% to ≤ 7.0% (%) | 17.4 | 25.6 | 16.2 | 2.5 | <0.0001 |
>7.0% to ≤ 7.5% (%) | 19.8 | 17.7 | 23.1 | 16.8 | <0.0001 |
SBP (mmHg) | 140.3 ± 15.7 | 139.5 ± 15.9 | 140.7 ± 15.5 | 141.3 ± 15.6 | <0.0001 |
DBP (mmHg) | 82.6 ± 9.5 | 82.4 ± 9.8 | 82.7 ± 9.2 | 83.0 ± 9.4 | <0.01 |
HR (beats/min) | 75.0 ± 10.0 | 74.7 ± 10.4 | 75.0 ± 9.4 | 75.9 ± 10.5 | <0.0001 |
Individualized treatment targets
Baseline characteristic | All subjects (n = 8,632*) | SBP ≤ 130 mmHg (n = 3,342) | SBP > 130 to ≤ 135 mmHg (n = 2,870) | SBP > 135 to ≤ 140 mmHg (n = 2,384) | P-values for the comparison of 3 groups |
---|---|---|---|---|---|
Age (years) | 65.0 (57.0-74.0) | 64.0 (55.0-72.0) | 66.0 (58.0-74.0) | 68.0 (59.0-75.0) | <0.0001 |
Age > 75 years (%) | 19.7 | 16.7 | 20.5 | 22.8 | <0.0001 |
Female sex (%) | 45.6 | 46.1 | 44.8 | 45.5 | 0.59 |
BMI (kg/m2) | 31.2 ± 5.9 | 31.1 ± 5.8 | 31.2 ± 5.7 | 31.4 ± 6.1 | 0.48 |
BMI > 30 kg/m2 (%) | 52.0 | 51.4 | 51.8 | 52.9 | 0.53 |
Waist circumference (cm) | 107.6 ± 14.5 | 107.8 ± 15.1 | 107.4 ± 13.7 | 107.5 ± 14.8 | 0.68 |
Current smokers (%) | 11.8 | 12.1 | 11.5 | 11.6 | 0.77 |
Diabetes duration (months) | 67.9 (31.7-117.3) | 61.4 (27.6-109.7) | 71.2 (34.1-120.2) | 72.7 (34.1-121.1) | <0.0001 |
Fasting glucose (mmol/l) | 8.5 ± 2.8 | 8.2 ± 2.7 | 8.7 ± 2.8 | 8.8 ± 2.9 | <0.0001 |
Postprandial glucose (mmol/l) | 10.9 ± 3.4 | 10.5 ± 3.2 | 11.2 ± 3.4 | 11.1 ± 3.6 | <0.0001 |
HbA1c (%) | 7.8 ± 2.1 | 7.5 ± 1.4 | 7.9 ± 1.4 | 8.1 ± 3.4 | <0.0001 |
SBP (mmHg) | 140.3 ± 15.7 | 136.4 ± 15.5 | 140.7 ± 14.8 | 145.2 ± 15.4 | <0.0001 |
≤ 130 mmHg (%) | 32.0 | 45.2 | 28.1 | 17.8 | <0.0001 |
> 130 to ≤ 135 mmHg (%) | 9.2 | 8.8 | 12.4 | 5.8 | <0.0001 |
> 135 to ≤ 140 mmHg (%) | 21.7 | 18.2 | 22.4 | 26.1 | <0.0001 |
DBP (mmHg) | 82.6 ± 9.5 | 81.3 ± 9.5 | 82.9 ± 9.1 | 84.1 ± 9.7 | <0.0001 |
HR (beats/min) | 75.0 ± 10.0 | 74.5 ± 10.0 | 75.2 ± 10.2 | 75.6 ± 10.2 | <0.0001 |
SBP > 135 to ≤ 140 mmHg | HbA1c >7.0% to ≤ 7.5% | |||
---|---|---|---|---|
uni (OR; 95%CI) | multi (OR; 95%CI) | uni (OR; 95%CI) | multi (OR; 95%CI) | |
Age (years) (≥ vs. < median) |
1.37 (1.24-1.51)
|
1.28 (1.04-1.56)
|
1.11 (1.00-1.24)
| 0.95 (0.74-1.21) |
Female sex (%) | 1.00 (0.91-1.10) | 1.01 (0.84-1.22) | 0.94 (0.85-1.05) | 1.22 (0.97-1.54) |
BMI (kg/m2) (≥ vs. < median) | 1.06 (0.96-1.16) | 1.07 (0.86-1.34) | 1.09 (0.98-1.22) | 0.94 (0.72-1.23) |
Waist circumference (cm) (≥ vs. < median) | 1.08 (0.91-1.27) | 1.01 (0.81-1.26) | 1.05 (0.87-1.28) | 1.00 (0.77-1.31) |
Current smokers (%) | 0.98 (0.84-1.14) | 1.13 (0.85-1.50) | 1.02 (0.86-1.21) | 1.15 (0.82-1.61) |
Diabetes duration (months) (≥ vs. < median) |
1.14 (1.03-1.26)
| 0.97 (0.80-1.17) |
1.50 (1.34-1.67)
|
1.36 (1.09-1.70)
|
FBG (mmol/l) (≥ vs. < median) |
1.38 (1.24-1.53)
|
1.29 (1.06-1.58)
|
2.31 (2.03-2.62)
| 1.24 (0.96-1.59) |
HbA1c (%)(≥ vs. < median) |
1.33 (1.20-1.47)
| 1.14 (0.93-1.41) |
4.03 (3.58-4.53)
|
3.20 (2.47-4.05)
|
SBP (mmHg) (≥ vs. < median) |
2.83 (2.54-3.14)
|
2.23 (1.84-2.70)
| 1.25 (1.12-1.40) | 1.22 (0.98-1.53) |
Prior MI (yes vs. no) | 0.87 (0.72-1.04) | 0.86 (0.61-1.20) | 1.05 (0.86-1.28) | 0.85 (0.57-1.27) |
Prior stroke/TIA (yes vs. no) | 1.09 (0.90-1.33) | 0.77 (0.54-1.10) | 1.11 (0.89-1.39) | 0.64 (0.41-0.99) |
Heart failure (yes vs. no) |
1.45 (1.27-1.66)
|
1.71 (1.33-2.21)
|
1.44 (1.23-1.67)
|
1.54 (1.13-2.09)
|
PAD (yes vs. no) |
1.43 (1.20-1.72)
|
1.46 (1.02-2.08)
|
1.51 (1.24-1.85)
|
1.92 (1.30-2.85)
|
Neuropathy (yes vs. no) | 0.99 (0.86-1.15) | 0.80 (0.61-1.04) |
1.45 (1.24-1.69)
|
1.60 (1.21-2.12)
|
NPDR (yes vs. no) | 0.89 (0.70-1.14) |
0.64 (0.41-0.99)
| 0.99 (0.75-1.31) | 0.83 (0.52-1.31) |
Antidiabetic and antihypertensive therapies by target group
Antidiabetic therapy | HbA1c ≤ 6.5% | HbA1c > 6.5% to ≤ 7.0% | HbA1c >7.0% to ≤ 7.5% | p-value at 6 mo* | |||
---|---|---|---|---|---|---|---|
6 mo | ∆BL | 6 mo | ∆BL | 6 mo | ∆BL | ||
Metformin (%) | 78.1 | -0.6 | 80.9 | -0.6 | 80.3 | +0.9 | <0.05 |
Sulfonylureas (%) | 15.8 | +0.6 | 19.1 | -0.3 | 21.7 | +0.1 | <0.0001 |
Alpha-glucosidase inhibitors (%) | 1.0 | 0.0 | 1.6 | +0.1 | 0.8 | -0.2 | <0.05 |
DPP-4 inhibitors (%) | 58.4 | -0.6 | 66.7 | +0.3 | 61.1 | -2.2 | <0.0001 |
Glinide (%) | 2.5 | +0.2 | 3.7 | -0.1 | 6.6 | +0.4 | <0.0001 |
Short-acting insulin (%) | 4.6 | +0.9 | 5.3 | +1.3 | 8.7 | +2.0 | <0.0001 |
Long-acting insulin (%) | 10.3 | +1.8 | 17.4 | +2.7 | 21.7 | +4.1 | <0.0001 |
Mixed insulin (%) | 0.9 | +0.2 | 2.2 | +0.3 | 3.7 | +0.8 | <0.0001 |
≥2 drugs (%) | 60.9 | +0.3 | 74.9 | +1.5 | 78.2 | +0.8 | <0.0001 |
Antihypertensive therapy
|
SBP ≤ 130 mmHg
|
SBP > 130 to ≤ 135 mmHg
|
SBP > 135 to ≤ 140 mmHg
|
p-value at 6 mo*
| |||
6 mo | ∆BL | 6 mo | ∆BL | 6 mo | ∆BL | ||
ACE inhibitors (%) | 50.9 | -0.4 | 53.2 | -0.8 | 54.2 | -0.1 | 0.08 |
ARBs (%) | 28.1 | +0.4 | 28.9 | +0.5 | 27.8 | +0.5 | 0.73 |
Aliskiren (%) | 0.4 | -0.1 | 0.5 | 0.0 | 0.3 | -0.1 | 0.74 |
Betablockers (%) | 48.4 | +0.6 | 47.8 | +0.6 | 47.6 | +0.7 | 0.87 |
Calcium blockers (%) | 25.7 | +0.6 | 29.3 | +0.8 | 31.8 | +1.0 | <0.0001 |
Diuretics (%) | 42.7 | +0.4 | 42.9 | +0.2 | 47.8 | +1.3 | <0.01 |
Other (%) | 8.9 | +0.2 | 10.5 | +0.4 | 12.8 | +0.1 | <0.001 |
≥2 drugs (%) | 63.3 | +0.6 | 68.4 | +0.3 | 70.0 | +1.5 | <0.0001 |
Six-month follow-up by HbA1c or SBP target group
HbA1c | HbA1c ≤ 6.5%(n = 2,647) | HbA1c > 6.5% to ≤ 7.0%(n = 2,790) | HbA1c >7.0% to ≤ 7.5%(n = 1,149) | P-values for the comparison of 3 groups |
---|---|---|---|---|
GP contacts (number) | 5.5 ± 4.8 | 4.7 ± 3.9 | 5.3 ± 4.4 | <0.001 |
Specialist contacts (number) | 2.3 ± 1.9 | 2.3 ± 2.7 | 2.3 ± 2.1 | <0.05 |
Fasting glucose (mmol/l) | 7.0 ± 2.0 | 7.4 ± 1.9 | 8.4 ± 2.8 | <0.0001 |
Postprandial glucose (mmol/l) | 8.4 ± 2.5 | 8.9 ± 2.7 | 9.8 ± 3.1 | <0.0001 |
HbA1c (%) | 6.8 ± 0.9 | 7.2 ± 0.9 | 7.7 ± 1.2 | <0.0001 |
∆HbA1c from baseline (%) | -0.4 ± 1.2 | -0.7 ± 1.2 | -0.9 ± 1.5 | <0.0001 |
SBP (mmHg) | 135.3 ± 14.1 | 135.8 ± 13.9 | 136.7 ± 14.1 | <0.01 |
∆SBP from baseline (mmHg) | -4.2 ± 16.7 | -5.1 ± 15.6 | -4.7 ± 15.5 | 0.06 |
DBP (mmHg) | 80.8 ± 8.8 | 80.3 ± 8.5 | 80.4 ± 8.5 | 0.27 |
SBP
|
SBP ≤ 130 mmHg (n = 2,602)
|
SBP > 130 to ≤ 135 mmHg (n = 2,225)
|
SBP > 135 to ≤ 140 mmHg (n = 1,729)
|
P-values for the comparison of 3 groups
|
GP contacts (number) | 5.5 ± 4.8 | 4.7 ± 3.7 | 5.2 ± 4.5 | <0.0001 |
Specialist contacts (number) | 2.3 ± 2.0 | 2.3 ± 2.4 | 2.3 ± 2.6 | 0.34 |
Fasting glucose (mmol/l) | 7.2 ± 2.2 | 7.4 ± 2.0 | 7.7 ± 2.3 | <0.0001 |
Postprandial glucose (mmol/l) | 8.8 ± 2.7 | 8.9 ± 2.3 | 8.9 ± 3.3 | <0.01 |
HbA1c (%) | 7.0 ± 1.1 | 7.2 ± 1.0 | 7.2 ± 1.1 | <0.0001 |
∆HbA1c from baseline (%) | -0.5 ± 1.2 | -0.7 ± 1.2 | -0.7 ± 1.3 | <0.0001 |
SBP (mmHg) | 133.4 ± 13.4 | 135.7 ± 13.3 | 139.1 ± 14.9 | <0.0001 |
∆SBP from baseline (mmHg) | -3.0 ± 16.5 | -5.2 ± 15.2 | -6.4 ± 16.3 | <0.0001 |
DBP (mmHg) | 79.9 ± 8.3 | 80.5 ± 8.2 | 81.4 ± 9.4 | <0.0001 |