Table 3.
HOMA-IR and HOMA-%β values (geometric mean and range) at TR baseline, DB and OLE endpoints
| Underweight <19 kg/m 2 | Normal-weight 19- < 25 kg/m 2 | Overweight 25- < 30 kg/m 2 | Obese ≥30 kg/m 2 | Overall | |
|---|---|---|---|---|---|
|
HOMA-IR | |||||
|
TR baseline |
|
|
|
|
|
| N |
22 |
191 |
200 |
133 |
546 |
| Geometric Mean |
1.5 |
1.7 |
2.4 |
4.3 |
2.4 |
| Range |
(0.66, 3.56) |
(0.74, 3.99) |
(1.11, 5.14) |
(1.86, 9.85) |
(0.99, 5.85) |
|
DB endpoint |
|
|
|
|
|
| N |
4 |
62 |
60 |
52 |
178 |
| Geometric Mean |
2.5 |
2.0 |
2.6 |
3.8 |
2.6 |
| Range |
(0.75, 8.17) |
(0.84, 4.64) |
(1.13, 5.80) |
(1.64, 8.86) |
(1.09, 6.33) |
|
OLE endpoint |
|
|
|
|
|
| N |
8 |
76 |
71 |
40 |
195 |
| Geometric Mean |
1.9 |
2.0 |
2.6 |
4.2 |
2.6 |
| Range |
(0.73, 4.81) |
(0.78, 5.03) |
(0.99, 6.97) |
(2.19, 8.25) |
(1.00, 6.56) |
|
HOMA-%β |
|
|
|
|
|
|
TR baseline |
|
|
|
|
|
| N |
22 |
191 |
200 |
133 |
546 |
| Geometric Mean |
90.4 |
93.8 |
123.4 |
175.9 |
120.7 |
| Range |
(50.65, 161.25) |
(46.18, 190.64) |
(63.20, 240.9) |
(82.53, 374.68) |
(57.47, 53.47) |
|
DB endpoint |
|
|
|
|
|
| N |
4 |
62 |
60 |
52 |
178 |
| Geometric Mean |
84.7 |
100.2 |
105.9 |
167.1 |
118.1 |
| Range |
(21.50, 333.65) |
(46.54, 215.73) |
(59.91, 187.1) |
(88.5, 315.3) |
(57.8, 241.2) |
|
OLE endpoint |
|
|
|
|
|
| N |
8 |
76 |
71 |
40 |
195 |
| Geometric Mean |
117.0 |
91.0 |
100.8 |
167.9 |
108.2 |
| Range | (50.71, 270.77) | (35.65, 232.06) | (47.68, 213.29) | (91.04, 309.64) | (46.99, 49.21) |
TR- transition; DB- double-blind; OLE- open-label extension.
HOMA-IR = Homeostatic Model Assessment for Insulin Resistance; HOMA-%β = Homeostatic Model Assessment for β-cell function. *HOMA-IR and HOMA-%β are expressed as the Geometric Mean (exp [mean {logs} – 1 * SD {logs}], exp [mean {logs} + 1 * SD {logs}]).