Table 2.
Metabolic parameters at TR baseline, DB endpoint and OLE endpoint (ITT analysis set)
| Underweight <19 kg/m 2 | Normal-weight 19- < 25 kg/m 2 | Overweight 25- < 30 kg/m 2 | Obese ≥30 kg/m 2 g | |
|---|---|---|---|---|
|
Plasma glucose, (mg/dL) |
|
|
|
|
| ITT analysis set with DB endpoint |
|
|
|
|
| n |
5 |
70 |
68 |
52 |
| TR baseline |
89.8 (14.65) |
92.6 (15.26) |
93.8 (12.88) |
101.3 (20.02) |
| Change from TR baseline to DB endpoint |
14.6 (18.39) |
2.0 (17.89) |
7.0 (20.81) |
−2.1 (24.20) |
| p-value |
0.1506 |
0.3563 |
0.0068 |
0.5313 |
| ITT analysis set with OLE endpoint |
|
|
|
|
| n |
8 |
85 |
77 |
39 |
| TR baseline |
90.4 (11.22) |
92.88 (19.71) |
94.64 (12.01) |
100.33. (15.59) |
| Change from TR baseline to OLE endpoint |
3.9 (18.36) |
10.2 (29.17) |
9.9 (29.00) |
3.5 (30.34) |
| p-value |
0.5694 |
0.0019 |
0.0036 |
0.4772 |
|
Insulin, (μU/mL) |
|
|
|
|
| ITT analysis set with DB endpoint |
|
|
|
|
| n |
4 |
61 |
63 |
50 |
| TR baseline |
17.0 (13.44) |
11.5 (15.23) |
12.6 (11.43) |
25.6 (32.12) |
| Change from TR baseline to DB endpoint |
−2.5 (4.36) |
−0.6 (16.56) |
3.2 (21.64) |
−4.3 (21.25) |
| p-value |
0.3345 |
0.7900 |
0.2517 |
0.1562 |
| ITT analysis set with OLE endpoint |
|
|
|
|
| n |
7 |
72 |
76 |
40 |
| TR baseline |
12.3 (11.23) |
11.1 (14.16) |
14.0 (12.37) |
25.0 (34.45) |
| Change from TR baseline to OLE endpoint |
0.3 (17.59) |
0.8 (13.71) |
1.5 (19.62) |
−5.25 (36.13) |
| p-value |
0.9671 |
0.6288 |
0.4928 |
0.3642 |
|
Cholesterol, (mg/dL) |
|
|
|
|
| ITT analysis set with DB endpoint |
|
|
|
|
| n |
5 |
71 |
64 |
52 |
| TR baseline |
170.8 (27.09) |
180.1 (39.40) |
192.7 (34.14) |
203.3 (39.23) |
| Change from TR baseline to DB endpoint |
−10.2 (36.27) |
−1.7 (28.87) |
−8.9 (26.99) |
−17.2 (34.78) |
| p-value |
0.5636 |
0.6320 |
0.0104 |
0.0008 |
| ITT analysis set with OLE endpoint |
|
|
|
|
| n |
8 |
85 |
75 |
40 |
| TR baseline |
161.9 (26.55) |
176.6 (34.37) |
194.0 (33.87) |
199.3 (31.05) |
| Change from TR baseline to OLE endpoint |
−3.25 (28.96) |
7.9 (30.87) |
−1.0 (36.04) |
1.0 (22.43) |
| p-value |
0.7602 |
0.0202 |
0.8034 |
0.7741 |
|
HDL, (mg/dL) |
|
|
|
|
| ITT analysis set with DB endpoint |
|
|
|
|
| n |
5 |
71 |
64 |
51 |
| TR baseline |
60.0 (6.44) |
55.9 (16.53) |
51.0 (12.16) |
46.5 (14.16) |
| Change from TR baseline to DB endpoint |
−2.8 (2.86) |
−1.6 (12.83) |
0.13 (8.93) |
−0.2 (9.27) |
| p-value |
0.0941 |
0.2828 |
0.9112 |
0.8805 |
| ITT analysis set with OLE endpoint |
|
|
|
|
| n |
8 |
85 |
75 |
39 |
| TR baseline |
56.7 (8.38) |
53.6 (14.15) |
50.7 (12.31) |
48.1 (10.75) |
| Change from TR baseline to OLE endpoint |
−0.2 (7.92) |
0.3 (13.46) |
−1.6 (10.75) |
1.0 (10.92) |
| p-value |
0.9314 |
0.8095 |
0.1869 |
0.5514 |
|
LDL, (mg/dL) |
|
|
|
|
| ITT analysis set with DB endpoint |
|
|
|
|
| n |
5 |
71 |
61 |
45 |
| TR baseline |
85.4 (18.80) |
101.7 (34.37) |
113.2 (30.01) |
126.3 (35.45) |
| Change from TR baseline to DB endpoint |
−6.0 (23.64) |
0.2 (26.18) |
−9.6 (23.10) |
−18.8 (28.82) |
| p-value |
0.6007 |
0.9388 |
0.0020 |
0.0001 |
| ITT analysis set with OLE endpoint |
|
|
|
|
| n |
8 |
82 |
72 |
38 |
| TR baseline |
83.2 (20.35) |
99.9 (30.97) |
113.3 (28.35) |
122.9 (28.98) |
| Change from TR baseline to OLE endpoint |
1.7 (21.67) |
6.8 (26.86) |
−0.1 (30.29) |
−2.1 (20.97) |
| p-value |
0.8259 |
0.0249 |
0.9814 |
0.5347 |
|
Triglycerides, (mg/dL) |
|
|
|
|
| ITT analysis set with DB endpoint |
|
|
|
|
| n |
5 |
71 |
64 |
52 |
| TR baseline |
124.4 (95.27) |
111.4 (57.31) |
155.6 (132.87) |
172.2 (101.48) |
| Change from TR baseline to DB endpoint |
−5.4 (79.94) |
−1.8 (54.93) |
−8.5 (129.2) |
−0.8 (97.12) |
| p-value |
0.8872 |
0.7813 |
0.5985 |
0.9535 |
| ITT analysis set with OLE endpoint |
|
|
|
|
| n |
8 |
85 |
75 |
40 |
| TR baseline |
107.7 (77.00) |
117.00 (72.70) |
158.7 (134.11) |
150.5 (67.13) |
| Change from TR baseline to OLE endpoint |
−22.6 (65.95) |
5.3 (87.44) |
−3.57 (135.8) |
13.8 (65.18) |
| p-value | 0.3642 | 0.5765 | 0.8203 | 0.1875 |
TR- transition; DB- double-blind; OLE- open-label extension; ITT- Intent-to-treat.
Changes from TR baseline to DB endpoint or OLE endpoint were calculated using data from those patients belonging to ITT analysis set with DB or OLE endpoint. All data values are expressed as mean (SD) and p-values are based on change from TR baseline scores and calculated using paired t-test.