Table 3.
Glucose Homeostasis
| Baseline | 2 Weeks | 3 Months | 6 Months | Δ after 6months | Treatment effect – all available data‡ |
P-value - all available data‡ |
P-value - imputation‡‡ (range of estimates) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tesamorelin | Placebo | Tesamorelin | Placebo | Tesamorelin | Placebo | Tesamorelin | Placebo | Tesamorelin | Placebo | ||||
| Fasting glucose (mg/dl) | 87 ± 8 n=28 |
91± 13 n=22 |
97 ± 12 † n=26 |
92 ± 11 n=21 |
94 ± 9 n=25 |
92 ± 10 n=20 |
91 ± 13 n=23 |
92 ± 16 n=20 |
4 (−2, 10) n=23 |
2 (−4, 7) N=20 |
0 [−6, 6] | 0.94 | 0.72 (−3, 3) |
| 2 hour glucose (mg/dl) | 114 ± 31 n=28 |
130 ± 29 n=22 |
(not measured) | 119 ± 43 n=25 |
125 ± 29 n=20 |
118 ± 44 n=22 |
123 ± 36 n=18 |
−1 (−18, 15) n=22 |
−8 (−24, 8) n=18 |
8 [−11, 27] | 0.43 | 0.53 (−6, 18) | |
| Fasting Insulin (μIU/ml) | 7.9 (4.7, 11.1) n=28 |
8.0 (3.9, 16.8) n=22 |
8.1 (4.7, 12.8) n=25 |
10.8 (6.8, 13.7) n=20 |
7.9 (4.8, 11.3) n=22 |
7.6 (4.5, 11.7) n=20 |
−0.2 (−2.6, 1.8) n=22 |
0.5 (−4.9, 3.0) n=20 |
0.6 [−3.5, 4.8] | 0.76 | 0.68 (−0.7, 2.3) | ||
| HOMA-IR | 1.6 (1.1, 2.5) n=28 |
1.9 (0.9, 3.6) n=22 |
1.8 (1.0, 3.0) n=25 |
2.6 (1.5, 2.9) n=20 |
1.7 (1.0, 2.5) n=22 |
1.7 (1.1, 3.0) n=20 |
0.0 (−0.8, 0.5) n=22 |
0.2 (−1.1, 0.8) n=20 |
0.4 [−0.7, 1.4] | 0.48 | 0.45 (0.0, 0.8) | ||
No statistically significant differences between groups at baseline. For normally distributed data, results are presented as the mean ± standard deviation at each timepoint, and change after 6 months is presented as mean (95% CI). Non-normally distributed data are presented as median with interquartile range (25%, 75%).
P-value and treatment effect [95% CI] for mixed effects model (time×randomization) using all available data over six months.
P-value for imputation analyses. Multiple imputation was performed by replacing missing values with imputed values calculated over 100 iterations, using longitudinal mixed effects modeling, and discarding the first 10 iterations. The p-value is the average of the p-values from the individual runs of the multiply imputed data sets. The values in parentheses provide a range (2.5th percentile, 97.5th percentile) of the estimated effect sizes for the imputation analyses.
Indicates significant change from baseline in tesamorelin vs. placebo groups, P < 0.05. Change from baseline at each timepoint was assessed using Student’s t-test.
Abbreviations: HOMA-IR: homeostasis model assessment of insulin resistance.
SI conversion factors: To convert glucose to mmol/L, multiply values by 0.0555. To convert insulin to pmol/L, multiple values by 6.945.