Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access
Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc
Journal website http://www.jocmr.org

Original Article

Volume 12, Number 7, July 2020, pages 423-430

Comprehensive Efficacy of the Dipeptidyl Peptidase 4 Inhibitor Alogliptin in Practical Clinical Settings: A Prospective Multi-Center Interventional Observational Study

Figure

Figure 1.
Figure 1. Flow diagram of study participants. HbA1c: hemoglobin A1c.

Tables

Table 1. Patient Characteristics
 
CharacteristicsN (%)
Data are the number (%) or means ± SD. SD: standard deviation; ACE: angiotensin-converting enzyme.
N50
Mean age (SD), years64.2 ± 11.7
Male28 (56)
Duration, years4.3 ± 3.8
Body mass index, kg/m226.0 ± 4.7
Clinical presentation
  Hypertension37 (74)
  Dyslipidemia35 (70)
  Hyperuricemia6 (12)
  Current smoking11 (22)
  Current drinking29 (48)
  Ischemic heart disease1 (2)
  Previous stroke5 (10)
  Diabetic retinopathy2 (4)
  Diabetic nephropathy7 (14)
  Diabetic neuropathy1 (2)
Medication
  Anti-hypertensive drugs
    Diuretic drugs8 (16)
    Calcium channel blockers24 (48)
    ACE inhibitors2 (4)
    Angiotensin II receptor blockers19 (38)
    Beta-blockers4 (8)
  Anti-dyslipidemic drugs
    Statin18 (36)
    Fibrates1 (2)
    Ezetimibe3 (6)
  Anti-thrombotic agents3 (6)

 

Table 2. Change in Parameters at 6 and 12 Months
 
0M6MP (vs. 0M)12MP (vs. 0M)P value (repeated measures ANOVA)
Data are the means ± standard deviation or the medians (interquartile range (IQR)). P values were obtained by the paired t-test. ANOVA: analysis of variance; SBP: systolic blood pressure; DBP: diastolic blood pressure; HR: heart rate; HbA1c: hemoglobin A1c; LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol; PLt: platelet; AST: aspartate transaminase; ALT: alanine transaminase; γ-GTP: gamma-glutamyl transpeptidase; UA: uric acid; eGFR: estimated glomerular filtration rate.
Body weight, kg (n = 46)67.0 ± 12.165.7 ± 12.9< 0.0165.7 ± 12.90.030.02
SBP, mm Hg (n = 48)136.9 ± 22.9129.7 ± 18.40.045130.0 ± 15.80.030.03
DBP, mm Hg (n = 48)81.2 ± 13.874.8 ± 11.7< 0.0175.6 ± 11.7< 0.01< 0.01
HR, bpm (n = 39)74.2 ± 11.673.5 ± 11.80.6876.3 ± 17.20.490.39
HbA1c, % (n = 50)7.5 ± 1.46.4 ± 0.9< 0.016.2 ± 0.7< 0.01< 0.01
Glucose, mg/dL (n = 36)172.1 ± 70.4138.9 ± 46.6< 0.01No data
LDL-C, mg/dL (n = 29)121.1 ± 26.9109.0 ± 27.2< 0.01114.0 ± 23.80.040.07
HDL-C, mg/dL (n = 31)54.3 ± 13.854.0 ± 15.10.7854.6 ± 16.60.420.5
Triglyceride, mg/dL (IQR) (n = 36)151 (117 - 220)127 (101 - 191)0.08123 (94 - 171)0.030.02
Non HDL-C, mg/dL (IQR) (n = 24)152 (126 - 169)137 (105 - 152)0.08145 (110 - 165)0.100.21
PLt, 106/µL (n = 29)22.6 ± 4.821.7 ± 3.90.0721.2 ± 3.20.030.07
AST, U/L (IQR) (n = 43)24 (22 - 32)21 (20 - 28)0.05424 (21 - 28)0.450.28
ALT, U/L (IQR) (n = 43)24 (20 - 47)21 (16 - 30)0.05426 (18 - 36)0.230.1
γ-GTP, U/L (IQR) (n = 36)42 (30 - 59)32 (23 - 49)< 0.0141 (23 - 55)0.030.08
UA, mg/dL (n = 30)5.0 ± 1.25.3 ± 1.00.185.4 ± 1.20.20.34
eGFR (n = 31)77.5 ± 22.374.0 ± 21.80.0875.8 ± 17.40.020.24

 

Table 3. Change in HbA1c at 6 and 12 Months According to the Different Age, Duration of Diabetes, BMI and Renal Function
 
HbA1c (6M) - HbA1c (0M)HbA1c (12M) - HbA1c (0M)
HbA1c: hemoglobin A1c; BMI: body mass index; eGFR: estimated glomerular filtration rate; 0M: 0 months (baseline); 6M: after 6 months of treatment; 12M: after 12 months of treatment.
Age < 65 years (n = 27)-1.37-1.35
Age ≥ 65 years (n = 23)-0.91-1.10
P value0.340.64
Duration < 5 years (n = 27)-1.20-1.20
Duration ≥ 5 years (n = 19)-1.19-1.41
P0.990.61
BMI < 25 (n = 24)-1.36-1.43
BMI ≥ 25 (n = 26)-0.97-1.04
P0.300.31
eGFR ≥ 60 (n = 30)-1.07-1.09
eGFR < 60 (n = 7)-0.79-0.92
P0.530.71

 

Table 4. Correlations of Various Factors With ΔHbA1c at 6 and 12 Months
 
rP
BMI: body mass index; SBP: systolic blood pressure; DBP: diastolic blood pressure; HR: heart rate; HbA1c: hemoglobin A1c; LDL-C: low-density lipoprotein cholesterol; TG: triglyceride; HDL-C: high-density lipoprotein cholesterol; ALT: alanine transaminase; γ-GTP: gamma-glutamyl transpeptidase; UA: uric acid; eGFR: estimated glomerular filtration rate; 0M: 0 months (baseline); 6M: after 6 months of treatment; 12M: after 12 months of treatment.
ΔHbA1c (HbA1c (0M) - HbA1c (6M)) 1.16 ± 1.29 (-0.6 to 5.5)
  Age-0.2540.075
  BMI-0.1920.191
  Duration-0.0210.892
  SBP (0M)0.3000.034
  DBP (0M)0.1810.209
  HR (0M)0.1080.466
  HbA1c (0M)0.768< 0.001
  LDL-C (0M)0.4440.007
  TG (0M)0.1740.309
  HDL-C (0M)-0.0890.608
  Non-HDL-C (0M)0.5810.003
  ALT (0M)-0.0100.955
  γ-GTP-0.2540.141
  UA (0M)-0.0360.834
  eGFR (0M)0.3470.035
ΔHbA1c (HbA1c (0M) - HbA1c (12M)) 1.23 ± 1.24 (-0.9 to 5.6)
  Age-0.0910.563
  BMI-0.2250.151
  Duration-0.0760.646
  SBP (0M)0.4470.030
  DBP (0M)0.2440.115
  HR (0M)0.2410.124
  HbA1c (0M)0.848< 0.001
  LDL-C (0M)0.1770.359
  TG (0M)0.0200.917
  HDL-C (0M)-0.0390.840
  Non-HDL-C (0M)0.4130.079
  ALT (0M)-0.2010.296
  γ-GTP-0.2730.160
  UA (0M)0.0710.714
  GFR (0M)0.1530.421

 

Table 5. Correlations of HbA1c 0M With ΔHbA1c (After Adjusting for SBP 0M) and SBP With ΔHbA1c (After Adjusting for HbA1c 0M)
 
rP
HbA1c: hemoglobin A1c; SBP: systolic blood pressure; 0M: 0 months (baseline); 6M: after 6 months of treatment; 12M: after 12 months of treatment.
ΔHbA1c (HbA1c (0M) - HbA1c (6M)) 1.16 ± 1.29 (-0.6 to 5.5)
  HbA1c (0M)0.743< 0.01
  SBP (0M)0.0740.612
ΔHbA1c (HbA1c (0M) - HbA1c (12M)) 1.23 ± 1.24 (-0.9 to 5.6)
  HbA1c (0M)0.810< 0.01
  SBP (0M)0.1420.369