TABLE 2.
Effects on glucose homeostasis at week 108 (ITT-LOCF)1
| Standardized lifestyle intervention across all treatment groups |
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| PHEN/TPM CR |
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| Placebo (n = 227) | 7.5/46 (n = 153) | 15/92 (n = 295) | |
| Fasting glucose (mg/dL) | |||
| Baseline | 109.3 ± 24.372 | 110.7 ± 25.28 | 108.2 ± 24.05 |
| LS change at 108 wk | 3.7 (0.8, 6.5)3 | 0.1 (−3.4, 3.7) | −1.2 (−3.8, 1.4) |
| P value vs placebo | N/A | 0.0872 | 0.0048 |
| Fasting insulin (μIU/mL) | |||
| Baseline | 17.5 ± 12.01 | 16.8 ± 12.25 | 17.7 ± 14.61 |
| LS change at 108 wk | −2.6 (−3.9, −1.3) | −5.3 (−6.9, −3.7) | −5.2 (−6.4, −4.0) |
| P value vs placebo | N/A | 0.0051 | 0.0012 |
| Hb A1c (%) | |||
| Baseline | 6.0 ± 0.90 | 6.0 ± 0.90 | 6.0 ± 0.85 |
| LS change at 108 wk | 0.2 (0.09, 0.2) | 0.01 (−0.08, 0.1) | 0.00 (−0.07, 0.07) |
| P value vs placebo | N/A | 0.0042 | 0.0003 |
1
Values represent changes from baseline (week 0) to week 108 (ITT-LOCF). Hb A1c, glycated hemoglobin; ITT, intent-to-treat; LOCF, last observation carried forward; LS, least-squares; N/A, not available; PHEN/TPM CR, controlled-release phentermine/topiramate; 7.5/46, 7.5 mg phentermine/46 mg controlled-release topiramate; 15/92, 15 mg phentermine/92 mg controlled-release topiramate.
2
Mean ± SD (all such values).
3
Mean; 95% CI in parentheses (all such values).