Supplemental Table 1. Summary of Key Efficacy and Safety Results at the Time Point Used

Supplemental Table 1. Summary of key efficacy and safety results at the time point used for this analysis, for the per-protocol analysis population (regardless of renal function) in each study.

Parameter / Study 1 [21]
(PN010) / Study 2[22,23]
(PN024) / Study 3[24]
(PN803)
Sitagliptin / Sulfonylurea / Sitagliptin / Sulfonylurea / Sitagliptin / Sulfonylurea
A1C (%)
Baseline
Week 25/30
Change from baseline‡
Change vs. Sulfonylurea / n = 76
7.8 ± 1.0
7.3 ± 0.9
-0.5a
(-0.7, -0.3)
0.3b
(0.0, 0.5) / n = 67
7.9 ± 1.0
7.1 ± 1.0
-0.8a
(-1.0, -0.6)
---- / n = 448
7.6 ± 0.8
6.8 ± 0.8
-0.8a
(-0.9, -0.7)
0.1b
(0.0, 0.2) / n = 477
7.6 ± 0.9
6.7 ± 0.7
-0.9a
(-0.9, -0.8)
---- / n = 443
7.5 ± 0.7
7.0 ± 0.8
-0.4a
(-0.5, -0.4)
0.1NS
(-0.0, 0.2) / n = 436
7.5 ± 0.7
7.0 ± 0.9
-0.5a
(-0.6, -0.4)
----
Patients with A1C Value < 7.0% at Week 25/30, n (%)
Difference in % vs.
Sulfonylurea† / 30 (39.5)
-15.8NS
(-31.4, 0.7) / 37 (55.2)
---- / 302 (67.4)
-0.5NS
(-6.6, 5.5) / 324 (67.9)
---- / 232 (52.4)
-7.3b
(-13.8, -0.7) / 260 (59.6)
----
Patients with A1C Reduction > 0.5% at Week 25/30, n (%)
Difference in % vs.
Sulfonylurea† / 29 (38.3)
-27.5a
(-42.4, -11.1) / 44 (65.7)
---- / 286 (63.8)
-0.1NS
(-6.3, 6.1) / 305 (63.9)
---- / 191 (43.1)
-3.0NS
(-9.5, 3.6) / 201 (46.1)
----
FPG (mg/dL)
Baseline
Week 25/30
Change from baseline‡
Change vs. Sulfonylurea / n=74
162.0 ± 39.1
151.1 ± 36.7
-14.1a
(-21.7, -6.6)
4.4NS
(-6.7, 15.4) / n=67
173.2 ± 43.1
151.1 ± 36.2
-18.5a
(-26.5, -10.5)
---- / n=442
160.5 ± 35.8
141.5 ± 33.9
-19.5a
(-22.2, -16.8)
2.3NS
(-1.5, 6.1) / n=476
162.0 ± 40.3
139.8 ± 31.6
-21.8a
(-24.4, -19.2)
---- / n=441
143.0 ± 32.5
130.4 ± 31.5
-13.4a
(-16.1, -10.7)
3.0NS
(-0.8, 6.9) / n=434
145.8 ± 33.9
128.5 ± 32.5
-16.5a
(-19.2, -13.7)
----
Patients with AE of Symptomatic Hypoglycemia
Week 25/30, n (%)
Difference in % vs.
Sulfonylurea† / 2 (2.6)
-12.3c
(-23.1, -3.5) / 10 (14.9)
---- / 22 (4.9)
-24.4a
(-29.1, -19.9) / 140 (29.4)
---- / 34 (7.7)
-15.3a
(-20.0, -10.6) / 100 (22.9)
----
Body Weight (kg)
Baseline
Week 25/30
Change from baseline‡
Change vs. Sulfonylurea / n=76
85.1 ± 16.8
85.4 ± 16.0
0.3NS
(-0.4, -0.9)
-1.1b
(-2.0, -0.1) / n=67
83.5 ± 17.5
84.8 ± 18.2
1.3a
(0.6, 2.0)
---- / n=438
89.2 ± 17.2
87.5 ± 17.3
-1.7a
(-2.0, -1.4)
-2.5a
(-2.8, -2.1) / n=467
90.0 ± 17.3
90.8 ± 17.6
0.7a
(0.5, 1.0)
---- / n=442
80.5 ± 15.4
79.8 ± 15.7
-0.8a
(-1.1, -0.5)
-2.0a
(-2.4, -1.6) / n=435
82.3 ± 16.5
83.5 ± 16.7
1.2a
(0.9, 1.5)
----
Data are reported as mean ± standard deviation unless noted otherwise.
‡Least squares mean (95% confidence interval), based on analysis of covariance with terms for treatment, study, and a covariate for baseline value.
†Based on Miettinen&Nurminen method.
aP<0.001; bP<0.05; cP<0.01; NSP is not significant
AE, adverse event; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin

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