Fig. 1(A) Percentage of patients who achieved the target glycosylated hemoglobin (HbA1c) levels of ≤7% and ≤6.5% assessed at baseline, 12, 24, and 52 weeks. (B) HbA1c levels (±SE) at baseline, 12, 24, and 52 weeks in patients with additional sitagliptin (open circles) or vildagliptin (black squares). aSignificant change in HbA1c level at week 52.
Fig. 2Glycosylated hemoglobin (HbA1c) levels (±SE) at baseline, 12, 24, and 52 weeks in rapid responders (open circles) and non-rapid responders (black squares).
Fig. 3(A) More women were among the patients with hypoglycemia symptoms (P=0.008). (B) Patients with hypoglycemia symptoms weighed less (P=0.003), (C) had lower concentrations of triglycerides (P=0.031), (D) lower fasting plasma glucose (P<0.001), and (E) had higher homeostasis model assessment of β-cell function (HOMA-β) levels (P=0.001). Hypo, patients who experienced hypoglycemia; Non-hypo, patients who did not experience hypoglycemia. aP<0.05.
Table 1Baseline characteristics of the patients (n=807)
Characteristic |
Value |
Age, yr |
61.1±11.5 |
Sex, male:female |
473:334 |
Duration of diabetes, yr |
11.5±6.9 |
Type of sulfonylurea, M:C:Ba
|
717:82:8 |
Dose of sulfonylurea, mg, M:C:Ba
|
4.1±2.1:84.9±62.3:8.4±3.0 |
Type of DPP-4 inhibitor, S:Vb
|
518:289 |
Dose of DPP-4 inhibitor, mg, S:Vb
|
97.9±10.1 |
Dose of metformin, mg |
1,241.9±483.8 |
Body mass index, kg/m2
|
25.5±3.4 |
Triglycerides, mg/dL |
153.4±101.4 |
HDL-C, mg/dL |
46.3±12.3 |
LDL-C, mg/dL |
84.3±26.2 |
AST, U/L |
24.4±11.5 |
ALT, U/L |
28.0±17.3 |
Creatinine, mg/dL |
1.0±0.3 |
Glycosylated hemoglobin, % |
8.4±1.2 |
Fasting plasma glucose, mg/dL |
153.4±47.8 |
2-Hour plasma glucose, mg/dL |
261.1±76.8 |
C-peptide, ng/mL |
2.2±1.3 |
Fasting insulin, µU/mL |
15.2±10.0 |
HOMA-β |
61.1±41.0 |
HOMA-IR |
2.1±1.2 |
Table 2Characteristics of rapid responders, patients with (HbA1cB-HbA1c12wk)/HbA1cB ≥25%, and non-rapid responders, patients with (HbA1cB-HbA1c12wk)/HbA1cB <25%
Characteristic |
Rapid responders (n=66) |
Non-rapid responders (n=715) |
P value |
Age, yr |
58.1±14.7 |
61.5±11.1 |
0.074 |
Sex, male:female |
47:19 |
407:308 |
0.027 |
Diabetes duration, yr |
8.8±11.7 |
11.7±7.0 |
0.002 |
Sulfonylurea type, M:C:Ba
|
60:6:0 |
635:73:7 |
- |
Sulfonylurea dose, M:C:Ba
|
3.7:60.0:0 |
4.1:87.4:8.9 |
- |
DPP-4 inhibitor type, S:Vb
|
41:25 |
455:260 |
0.791 |
DPP-4 inhibitor dose, mg, S:Vb
|
100.0:98.0 |
97.8:97.9 |
- |
Metformin dose, mg |
1,293.0±448.4 |
1,233.5±487.9 |
0.349 |
Body mass index, kg/m2
|
25.5±4.1 |
25.5±3.3 |
0.922 |
Triglyceride, mg/dL |
152.3±124.1 |
152.6±99.2 |
0.982 |
HDL-C, mg/dL |
47.7±9.6 |
46.3±12.6 |
0.375 |
LDL-C, mg/dL |
88.2±28.2 |
83.8±26.0 |
0.206 |
AST, U/L |
25.1±12.9 |
24.3±11.5 |
0.582 |
ALT, U/L |
31.0±18.6 |
27.7±17.2 |
0.138 |
Creatinine, mg/dL |
0.9±0.3 |
1.0±0.3 |
0.839 |
HbA1c, % |
10.1±1.4 |
8.2±1.1 |
<0.001 |
Fasting plasma glucose, mg/dL |
174.3±67.4 |
150.9±44.0 |
0.007 |
2-Hour plasma glucose, mg/dL |
288.6±111.3 |
257.3±70.0 |
0.162 |
C-peptide, ng/mL |
3.0±1.8 |
2.1±1.2 |
0.030 |
Fasting insulin, µU/mL |
17.3±14.1 |
15.0±9.3 |
0.264 |
HOMA-β |
71.2±58.6 |
60.1±37.0 |
0.279 |
HOMA-IR |
2.5±1.3 |
2.1±1.2 |
0.044 |
Hypoglycemic symptomsc
|
16 (24.2) |
96 (13.4) |
0.026 |
Sulfonylurea reduction |
44 (66.7) |
130 (18.2) |
0.005 |
Table 3Logistic regression analysis for parameters that predict rapid responders to dipeptidyl peptidase-4 inhibitor add-on therapy to a sulfonylurea and metformin combination
Parameter |
β Coefficient |
SE |
Odds ratio (95% CI) |
P value |
Male sex |
0.689 |
0.357 |
1.992 (0.989-4.013) |
0.054 |
Baseline HbA1c |
-0.061 |
0.03 |
0.941 (0.888-0.997) |
0.040 |
Duration of diabetes |
1.133 |
0.138 |
3.106 (2.370-4.070) |
<0.001 |