Background
Methods
Study design and randomization
Population
Outcomes and assessments
Statistical analysis
Results
Fotagliptin group (n = 227) | Alogliptin group (n = 110) | Placebo group (n = 113) | P | |
---|---|---|---|---|
Age (years) | 53.0 (9.03) | 53.7 (10.37) | 54.2 (9.75) | 0.4508 |
Male [n (%)] | 140 (61.7) | 70 (63.6) | 72 (63.7) | 0.9080 |
BMI (kg/m2) | 25.67 (3.12) | 25.69 (3.07) | 25.65 (2.91) | 0.9911 |
Weight (kg) | 70.77 (11.18) | 69.76 (11.69) | 69.20 (11.45) | 0.2494 |
SBP (mmHg) | 124.9 (11.6) | 126.4 (12.5) | 125.3 (12.0) | 0.5502 |
DBP (mmHg) | 81.1 (7.9) | 81.9 (8.0) | 81.0 (7.4) | 0.7377 |
eGFR (ml/min per 1.73 m2) | 104.92 (11.45) | 101.84 (14.19) | 102.18 (13.98) | 0.0276 |
ALT (U/L) | 23.0 (17.0, 33.0) | 21.9 (15.0, 33.0) | 24.0 (16.0, 35.3) | 0.3979 |
AST (U/L) | 20.0 (16.3, 25.7) | 21.0 (16.0, 27.0) | 21.0 (17.0, 27.0) | 0.5847 |
Duration of diabetes (months) | 11.00 (1.80,36.50) | 13.20 (2.70,38.60) | 19.25 (2.35,34.85) | 0.6666 |
FPG (mmol/L) | 9.34 (1.79) | 9.40 (2.06) | 9.47 (1.79) | 0.8566 |
HbA1c (%) | 8.08 (0.73) | 8.10 (0.74) | 8.12 (0.70) | 0.8495 |
Fasting insulin (μIU/ml) | 10.67 (7.55,15.80) | 10.36 (6.61,16.32) | 10.58 (7.19,15.04) | 0.7627 |
Fasting C-peptide (ng/ml) | 2.49 (2.01,3.14) | 2.37 (1.96,3.07) | 2.51 (1.93,3.27) | 0.5884 |
HOMA-β | 35.62 (23.40,53.77) | 33.14 (20.46,57.54) | 32.91 (22.89,48.21) | 0.4523 |
HOMA-IR | 4.45 (3.10,6.93) | 4.61 (2.66,6.41) | 4.47 (2.94,7.03) | 0.8199 |
Mean change from baseline to week 24 | ||||
Fotagliptin group | Alogliptin group | Placebo group | P | |
Fasting insulin (μIU/ml) | 0.73(-0.13,1.59) | 0.44(-0.51,1.38) | -0.11(-1.18,0.96) | 0.671 |
Fasting C-peptide (pmol/L) | 0.13(0.03,0.23) | 0.08(-0.03,0.19) | -0.05(-0.16,0.06) | 0.146 |
HOMA-β | 11.00(7.46,14.55) | 7.21(3.39,11.02) | 4.61(0.66,8.56) | 0.066 |
HOMA-IR | -0.12(-0.58,0.33) | -0.16(-0.63,0.30) | -0.46(-0.99,0.06) | 0.980 |
ALT (U/L) | -2.26(-3.64,-0.89) | -2.31(-4.17,-0.44) | 4.82(-5.99,15.63) | 0.820 |
AST (U/L) | -1.01(-1.83,-0.19) | -0.81(-2.10,0.48) | 1.94(-3.79,7.68) | 0.836 |
Serum creatinine (umol/L) | 2.28(1.19,3.37) | -0.50(-1.96,0.96) | 0.76(-0.97,2.49) | 0.018 |
eGFR (ml/min per 1.73 m2) | -1.83(-2.85,-0.80) | 0.90(-0.39,2.19) | -0.96(-2.64,0.73) | 0.018 |
LDL-C (mmol/L) | 0.02(-0.07,0.11) | -0.04(-0.16,0.09) | 0.06(-0.07,0.19) | 0.225 |
TG (mmol/L) | 0.15(-0.08,0.37) | 0.23(0.01,0.44) | -0.12(-0.28,0.04) | 0.261 |
Serum amylase (U/L) | 4.10(1.89,6.30) | 1.92(-1.36,5.20) | 0.52(-2.27,3.32) | 0.107 |
Serum lipase (U/L) | 6.35(2.02,10.67) | 6.14(3.03,9.25) | 0.67(-1.29,2.63) | 0.003 |
Mean change from baseline to week 52 | ||||
Fotagliptin group | Alogliptin group | Control group | P | |
Fasting insulin (μIU/ml) | -0.52(-1.29,0.26) | 0.24(-0.95,1.43) | 0.16(-1.12,1.44) | 0.661 |
Fasting C-peptide (pmol/L) | 0.07(-0.01,0.15) | 0.14(-0.00,0.28) | 0.14(-0.02,0.29) | 0.640 |
HOMA-β | 3.76(0.56,6.96) | 4.42(-0.08,8.93) | 6.94(1.96,11.92) | 0.648 |
HOMA-IR | -0.44(-0.91,0.04) | -0.20(-0.79,0.40) | -0.36(-1.03,0.31) | 0.630 |
ALT (U/L) | -0.37(-2.15,1.41) | -1.25(-3.35,0.86) | 2.28(-1.59,6.14) | 0.697 |
AST (U/L) | 0.22(-0.75,1.19) | -0.53(-1.77,0.71) | 1.77(-0.22,3.76) | 0.443 |
Serum creatinine (umol/L) | 3.15(1.60,4.71) | 0.67(-1.17,2.51) | 2.66(0.84,4.48) | 0.144 |
eGFR (ml/min per 1.73 m2) | -2.34(-3.54,-1.14) | -0.62(-2.40,1.15) | -2.24(-3.88,-0.59) | 0.184 |
LDL-C (mmol/L) | 0.03(-0.07,0.13) | -0.04(-0.18,0.11) | 0.04(-0.11,0.20) | 0.676 |
TG (mmol/L) | 0.27(-0.05,0.58) | 0.22(0.02,0.42) | -0.06(-0.32,0.21) | 0.111 |
Serum amylase (U/L) | 4.59(3.07,6.10) | 3.16(0.79,5.54) | 5.62(2.51,8.72) | 0.744 |
Serum lipase (U/L) | 6.83(4.30,9.35) | 6.37(3.56,9.18) | 6.65(3.90,9.41) | 0.113 |
Fotagliptin group | Alogliptin group | Placebo group | P | ||
---|---|---|---|---|---|
Serious adverse events that were present in more than 2% of the patients in either trial group, n (%) | |||||
Double-blind stage | - | - | - | - | - |
Extended stage | - | - | - | - | - |
Adverse events that were considered to be related to therapeutic drug or placebo in more than 5% of the patients in either trial group, n (%) | |||||
Double-blind stage | Lipase increased | 7 (3.1) | 10 (9.1)# | 2 (1.8) | 0.0217 |
Extended stage | - | - | - | - | - |
Any other safety events of special interest, n (%) | |||||
Double-blind stage | Hypoglycemia | 2 (0.9)* | 0 (0.0)# | 7 (6.2) | 0.0038 |
Myocardial ischaemia | 2 (0.9) | 2 (1.8) | 2 (1.8) | 0.6441 | |
Arteriosclerosis coronary artery | 2 (0.9) | 0 (0.0) | 1 (0.9) | 1.0000 | |
Acute coronary syndrome | 1 (0.4) | 0 (0.0) | 0 (0.0) | 1.0000 | |
Extended stage | Hypoglycemia | 2 (1.0) | 1 (1.0) | 4 (3.8) | 0.1604 |
Myocardial ischaemia | 2 (1.0) | 0 (0.0) | 2 (1.9) | 0.5587 | |
Angina pectoris | 1 (0.5) | 0 (0.0) | 0 (0.0) | 1.0000 | |
Arteriosclerosis coronary artery | 1 (0.5) | 0 (0.0) | 1 (1.0) | 1.000 | |
Any adverse events more than 5% in either trial group | |||||
Double-blind stage | Dyslipidemia | 28 (12.3) | 17 (15.5) | 15 (13.3) | 0.7600 |
Hyperuricemia | 18 (7.9) | 7 (6.4) | 3 (2.7) | 0.1622 | |
Urinary tract infection | 13 (5.7) | 9 (8.2) | 7 (6.2) | 0.7051 | |
Upper respiratory tract infection | 14 (6.1) | 8 (7.3) | 6 (5.3) | 0.8416 | |
Lipase increased | 8 (3.5) | 11 (10.0)## | 2 (1.8) | 0.0081 | |
Hypoglycemia | 2 (0.9)* | 0 (0.0)# | 7 (6.2) | 0.0038 | |
Extended stage | Dyslipidemia | 17 (8.2) | 10 (10.2) | 5 (4.8) | 0.3880 |
Hyperuricemia | 4 (1.9) | 7 (7.1) | 7 (6.7) | 0.0347 | |
Abnormal hepatic function | 6 (2.9) | 4 (4.1) | 6 (5.8) | 0.4256 |