Fig. 1Study flow chart. Group A: intensifying oral hypoglycemic agents (OHAs; sulfonylurea+metformin dose titration or fixed-dose combination added to other OHAs). Group B: basal insulin alone or added to OHA mono/combination therapy. Group C: basal bolus, premixed insulin, and continuous subcutaneous insulin infusion alone or added to OHA mono/combination therapy. HbA1c, glycosylated hemoglobin.
Fig. 2Change in (A) glycosylated hemoglobin (HbA1c) and (B) fasting plasma glucose (FPG). Group A: oral hypoglycemic agents (OHAs; sulfonylurea+metformin dose titration or fixed-dose combination added to other OHAs). Group B: basal insulin alone or added to OHA mono/combination therapy. Group C: basal insulin plus rapid acting insulin combination therapy alone or added to OHA mono/combination therapy. P value was calculated by analysis of covariance with adjustment of baseline HbA1c.
Table 1Baseline clinical and biochemical characteristics by prescription group
Characteristic |
Group A |
Group B |
Group C |
Total |
P value |
Number |
0504 |
2,316 |
81 |
2,901 |
|
Male sex |
284 (56.4) |
1,245 (53.8) |
32 (39.5) |
1,561 (53.8) |
0.020 |
Age, yr |
58.3±10.8 |
58.8±10.9 |
59.4±11.3 |
58.8±10.9 |
0.508 |
Body weight, kg |
68.1±11.2a
|
65.4±10.6b
|
60.2±12.2c
|
65.7±10.8 |
<0.001 |
BMI, kg/m2
|
25.4±3.1a
|
24.3±3.0b
|
23.4±3.9c
|
24.4±3.0 |
<0.001 |
Diabetes duration, yr |
7.3±5.1a
|
7.9±5.5a
|
9.7±5.5b
|
7.8±5.5 |
0.005 |
HbA1c, % |
8.4±1.1a
|
9.1±1.4b
|
10.3±2.3c
|
9.0±1.4 |
<0.001 |
FPG, mg/dL |
178±61a
|
200±61b
|
193±74a,b
|
196±61 |
<0.001 |
Metformin dose, mg |
1,242±521a
|
1,234±513a
|
1,078±489b
|
1,231±514 |
0.024 |
Sulfonyluread
|
|
|
|
|
|
Glimepiride |
370 (73.3) |
2,093 (90.2) |
75 (91.5) |
2,538 (87.3) |
<0.001 |
Gliclazide |
104 (20.6) |
150 (6.5) |
3 (3.7) |
257 (8.8) |
<0.001 |
Glibenclamide |
31 (6.1) |
78 (3.4) |
4 (4.9) |
113 (3.9) |
0.014 |
Table 2Percentage of patients who achieved target HbA1ca, target fasting plasma glucoseb, and change in body weight from baseline to each visit by prescription group
Variable |
Group A |
Group B |
Group C |
P value |
Number |
0504 |
2,316 |
81 |
|
Proportion of patients, % (HbA1c <7.0%) |
|
|
|
|
At 3 months |
17.1 |
10.2 |
30 |
0.001 |
At 6 months |
40.9 |
39.6 |
35.8 |
0.666 |
Proportion of patients, % (HbA1c <6.5%) |
|
|
|
|
At 3 months |
7.1 |
3.6 |
5.0 |
0.535 |
At 6 months |
17.3 |
8.7 |
18.5 |
<0.001 |
Proportion of patients, % (FPG <130 mg/dL) |
|
|
|
|
At 3 months |
25.3 |
29.7 |
46.2 |
0.004 |
At 6 months |
30.5 |
56.1 |
53.9 |
<0.001 |
∆ Body weight, kg |
|
|
|
|
At 6 months |
0.1±2.6 |
0.3±1.9 |
0.6±2.5 |
0.606 |
∆ BMI, kg/m2
|
|
|
|
|
At 6 months |
0.08±1.18 |
0.11±0.79 |
0.39±1.18 |
0.113 |