Mean changes from baseline (modified intent to treat, last observation carried forward) in primary and key secondary end points
| . | Placebo . | . | . | . | Topiramate CR 175 mg/day . | . | . | . | P for between-treatment group difference . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | n . | Baseline . | Week 16 . | Mean change from baseline . | n . | Baseline . | Week 16 . | Mean change from baseline . | . | ||||||
| Body weight (kg) | 55 | 109.7 ± 19.6 | 107.3 ± 19.7 | −2.5 ± 3.1 | 54 | 106.0 ± 17.2 | 100.0 ± 18.1 | −6.0 ± 5.2 | <0.001 | ||||||
| % change from baseline | −2.3 ± 2.9 | −5.8 ± 4.8 | <0.001 | ||||||||||||
| Anthropomorphic measurements | |||||||||||||||
| BMI (kg/m2) | 55 | 37.7 ± 5.8 | 36.9 ± 5.9 | −0.8 ± 1.1 | 54 | 38.1 ± 5.3 | 36.0 ± 5.9 | −2.1 ± 1.8 | <0.001 | ||||||
| Waist circumference (cm) | 52 | 114.7 ± 11.9 | 112.5 ± 11.6 | −2.3 ± 4.7 | 47 | 115.4 ± 11.4 | 111.2 ± 12.7 | −4.2 ± 5.7 | 0.078 | ||||||
| Hip circumference (cm) | 52 | 123.0 ± 13.1 | 122.0 ± 13.1 | −1.0 ± 4.7 | 47 | 122.2 ± 12.1 | 119.0 ± 12.7 | −3.2 ± 4.5 | 0.012 | ||||||
| Glycemic control parameters | |||||||||||||||
| A1C (%) | 55 | 7.4 ± 0.83 | 7.1 ± 0.89 | −0.4 ± 0.80 | 52 | 7.6 ± 0.92 | 6.7 ± 0.85 | −0.9 ± 0.77 | <0.001 | ||||||
| Fasting plasma glucose (mmol/l) | 55 | 9.3 ± 2.1 | 8.7 ± 1.8 | −0.6 ± 1.8 | 52 | 9.2 ± 2.1 | 7.6 ± 2.2 | −1.6 ± 2.0 | 0.002 | ||||||
| HOMA | |||||||||||||||
| Pancreatic β-cell function (%) | 50 | 43.7 ± 36.0 | 43.6 ± 26.6 | −0.1 ± 27.9 | 45 | 54.7 ± 69.4 | 54.8 ± 75.7 | 0.0 ± 71.5 | 0.665 | ||||||
| Insulin resistance | 50 | 4.8 ± 4.6 | 4.0 ± 2.3 | −0.8 ± 4.3 | 45 | 5.7 ± 4.3 | 4.6 ± 4.1 | −1.1 ± 3.6 | 0.583 | ||||||
| OGTT | |||||||||||||||
| Fasting plasma glucose (mmol/l) | 44 | 9.2 ± 1.9 | 8.6 ± 1.8 | −0.6 ± 1.8 | 39 | 9.3 ± 2.1 | 7.4 ± 2.3 | −1.9 ± 1.8 | 0.001 | ||||||
| 2-h plasma glucose (mmol/l) | 48 | 16.4 ± 3.8 | 15.3 ± 3.7 | −1.1 ± 2.9 | 42 | 15.7 ± 3.2 | 13.1 ± 4.1 | −2.6 ± 4.1 | 0.018 | ||||||
| Baseline plasma insulin (μIU/ml) | 52 | 11.3 ± 9.7 | 10.3 ± 5.1 | −1.1 ± 8.4 | 45 | 13.6 ± 10.1 | 12.7 ± 10.1 | −1.0 ± 6.62 | 0.279 | ||||||
| 2-h plasma insulin (μIU/ml) | 47 | 34.6 ± 27.4 | 34.1 ± 23.3 | −0.5 ± 18.2 | 41 | 45.1 ± 48.5 | 54.5 ± 43.6 | 9.5 ± 40.0 | 0.009 | ||||||
| Mean blood pressure | |||||||||||||||
| Systolic (mmHg) | 55 | 127.9 ± 15.16 | 123.7 ± 14.3 | −4.2 ± 12.9 | 54 | 127.2 ± 12.5 | 117.1 ± 11.8 | −10.2 ± 12.8 | 0.004 | ||||||
| Diastolic (mmHg) | 55 | 78.4 ± 8.9 | 76.8 ± 10.6 | −1.6 ± 8.7 | 54 | 79.1 ± 7.1 | 73.8 ± 8.5 | −5.3 ± 8.5 | 0.032 | ||||||
| Urinary albumin-to-creatinine ratio (mg/mg creatinine) | 43 | 0.031 ± 0.047 | 0.029 ± 0.051 | −0.002 ± 0.038 | 39 | 0.046 ± 0.086 | 0.018 ± 0.025 | −0.028 ± 0.071 | 0.033 | ||||||
| Lipid profile* | |||||||||||||||
| Total cholesterol (mmol/l) | 53 | 5.37 ± 1.01 | 5.28 ± 1.03 | −1.4 ± 11.6* | 46 | 5.53 ± 1.31 | 5.16 ± 1.22 | −5.9 ± 12.2* | 0.109 | ||||||
| LDL cholesterol (mmol/l) | 53 | 3.27 ± 0.89 | 3.34 ± 0.90 | 3.4 ± 19.1* | 46 | 3.40 ± 1.04 | 3.29 ± 0.98 | −1.7 ± 16.1* | 0.250 | ||||||
| HDL cholesterol (mmol/l) | 53 | 1.25 ± 0.33 | 1.28 ± 0.31 | 3.5 ± 13.2* | 46 | 1.18 ± 0.31 | 1.15 ± 0.28 | −1.6 ± 11.3* | 0.016 | ||||||
| Triglycerides (mmol/l) | 52 | 1.73 ± 0.67 | 1.76 ± 0.72 | 6.4 ± 40.0* | 46 | 2.02 ± 1.22 | 1.72 ± 1.09 | −7.3 ± 34.6* | 0.246 | ||||||
| Total-to-HDL cholesterol ratio | 53 | 4.54 ± 1.30 | 4.29 ± 1.04 | −0.25 ± 0.68 | 46 | 4.93 ± 1.63 | 4.66 ± 1.34 | −0.28 ± 0.89 | 0.410 | ||||||
| LDL-to-HDL cholesterol ratio | 53 | 2.79 ± 1.03 | 2.73 ± 0.84 | −0.06 ± 0.53 | 46 | 3.06 ± 1.25 | 2.99 ± 1.06 | −0.06 ± 0.68 | 0.413 | ||||||
| Other end points | |||||||||||||||
| Adiponectin (ng/ml) | 52 | 5,068 ± 2,729 | 5,514 ± 3,641 | 446 ± 1,655 | 45 | 4,644 ± 2,464 | 5,741 ± 3,146 | 1,098 ± 1,862 | 0.058 | ||||||
| C-reactive protein (mg/l) | 53 | 7.1 ± 6.7 | 7.1 ± 7.5 | 0.0 ± 3.9 | 46 | 7.7 ± 6.1 | 6.7 ± 7.6 | −1.1 ± 6.3 | 0.522 | ||||||
| . | Placebo . | . | . | . | Topiramate CR 175 mg/day . | . | . | . | P for between-treatment group difference . | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | n . | Baseline . | Week 16 . | Mean change from baseline . | n . | Baseline . | Week 16 . | Mean change from baseline . | . | ||||||
| Body weight (kg) | 55 | 109.7 ± 19.6 | 107.3 ± 19.7 | −2.5 ± 3.1 | 54 | 106.0 ± 17.2 | 100.0 ± 18.1 | −6.0 ± 5.2 | <0.001 | ||||||
| % change from baseline | −2.3 ± 2.9 | −5.8 ± 4.8 | <0.001 | ||||||||||||
| Anthropomorphic measurements | |||||||||||||||
| BMI (kg/m2) | 55 | 37.7 ± 5.8 | 36.9 ± 5.9 | −0.8 ± 1.1 | 54 | 38.1 ± 5.3 | 36.0 ± 5.9 | −2.1 ± 1.8 | <0.001 | ||||||
| Waist circumference (cm) | 52 | 114.7 ± 11.9 | 112.5 ± 11.6 | −2.3 ± 4.7 | 47 | 115.4 ± 11.4 | 111.2 ± 12.7 | −4.2 ± 5.7 | 0.078 | ||||||
| Hip circumference (cm) | 52 | 123.0 ± 13.1 | 122.0 ± 13.1 | −1.0 ± 4.7 | 47 | 122.2 ± 12.1 | 119.0 ± 12.7 | −3.2 ± 4.5 | 0.012 | ||||||
| Glycemic control parameters | |||||||||||||||
| A1C (%) | 55 | 7.4 ± 0.83 | 7.1 ± 0.89 | −0.4 ± 0.80 | 52 | 7.6 ± 0.92 | 6.7 ± 0.85 | −0.9 ± 0.77 | <0.001 | ||||||
| Fasting plasma glucose (mmol/l) | 55 | 9.3 ± 2.1 | 8.7 ± 1.8 | −0.6 ± 1.8 | 52 | 9.2 ± 2.1 | 7.6 ± 2.2 | −1.6 ± 2.0 | 0.002 | ||||||
| HOMA | |||||||||||||||
| Pancreatic β-cell function (%) | 50 | 43.7 ± 36.0 | 43.6 ± 26.6 | −0.1 ± 27.9 | 45 | 54.7 ± 69.4 | 54.8 ± 75.7 | 0.0 ± 71.5 | 0.665 | ||||||
| Insulin resistance | 50 | 4.8 ± 4.6 | 4.0 ± 2.3 | −0.8 ± 4.3 | 45 | 5.7 ± 4.3 | 4.6 ± 4.1 | −1.1 ± 3.6 | 0.583 | ||||||
| OGTT | |||||||||||||||
| Fasting plasma glucose (mmol/l) | 44 | 9.2 ± 1.9 | 8.6 ± 1.8 | −0.6 ± 1.8 | 39 | 9.3 ± 2.1 | 7.4 ± 2.3 | −1.9 ± 1.8 | 0.001 | ||||||
| 2-h plasma glucose (mmol/l) | 48 | 16.4 ± 3.8 | 15.3 ± 3.7 | −1.1 ± 2.9 | 42 | 15.7 ± 3.2 | 13.1 ± 4.1 | −2.6 ± 4.1 | 0.018 | ||||||
| Baseline plasma insulin (μIU/ml) | 52 | 11.3 ± 9.7 | 10.3 ± 5.1 | −1.1 ± 8.4 | 45 | 13.6 ± 10.1 | 12.7 ± 10.1 | −1.0 ± 6.62 | 0.279 | ||||||
| 2-h plasma insulin (μIU/ml) | 47 | 34.6 ± 27.4 | 34.1 ± 23.3 | −0.5 ± 18.2 | 41 | 45.1 ± 48.5 | 54.5 ± 43.6 | 9.5 ± 40.0 | 0.009 | ||||||
| Mean blood pressure | |||||||||||||||
| Systolic (mmHg) | 55 | 127.9 ± 15.16 | 123.7 ± 14.3 | −4.2 ± 12.9 | 54 | 127.2 ± 12.5 | 117.1 ± 11.8 | −10.2 ± 12.8 | 0.004 | ||||||
| Diastolic (mmHg) | 55 | 78.4 ± 8.9 | 76.8 ± 10.6 | −1.6 ± 8.7 | 54 | 79.1 ± 7.1 | 73.8 ± 8.5 | −5.3 ± 8.5 | 0.032 | ||||||
| Urinary albumin-to-creatinine ratio (mg/mg creatinine) | 43 | 0.031 ± 0.047 | 0.029 ± 0.051 | −0.002 ± 0.038 | 39 | 0.046 ± 0.086 | 0.018 ± 0.025 | −0.028 ± 0.071 | 0.033 | ||||||
| Lipid profile* | |||||||||||||||
| Total cholesterol (mmol/l) | 53 | 5.37 ± 1.01 | 5.28 ± 1.03 | −1.4 ± 11.6* | 46 | 5.53 ± 1.31 | 5.16 ± 1.22 | −5.9 ± 12.2* | 0.109 | ||||||
| LDL cholesterol (mmol/l) | 53 | 3.27 ± 0.89 | 3.34 ± 0.90 | 3.4 ± 19.1* | 46 | 3.40 ± 1.04 | 3.29 ± 0.98 | −1.7 ± 16.1* | 0.250 | ||||||
| HDL cholesterol (mmol/l) | 53 | 1.25 ± 0.33 | 1.28 ± 0.31 | 3.5 ± 13.2* | 46 | 1.18 ± 0.31 | 1.15 ± 0.28 | −1.6 ± 11.3* | 0.016 | ||||||
| Triglycerides (mmol/l) | 52 | 1.73 ± 0.67 | 1.76 ± 0.72 | 6.4 ± 40.0* | 46 | 2.02 ± 1.22 | 1.72 ± 1.09 | −7.3 ± 34.6* | 0.246 | ||||||
| Total-to-HDL cholesterol ratio | 53 | 4.54 ± 1.30 | 4.29 ± 1.04 | −0.25 ± 0.68 | 46 | 4.93 ± 1.63 | 4.66 ± 1.34 | −0.28 ± 0.89 | 0.410 | ||||||
| LDL-to-HDL cholesterol ratio | 53 | 2.79 ± 1.03 | 2.73 ± 0.84 | −0.06 ± 0.53 | 46 | 3.06 ± 1.25 | 2.99 ± 1.06 | −0.06 ± 0.68 | 0.413 | ||||||
| Other end points | |||||||||||||||
| Adiponectin (ng/ml) | 52 | 5,068 ± 2,729 | 5,514 ± 3,641 | 446 ± 1,655 | 45 | 4,644 ± 2,464 | 5,741 ± 3,146 | 1,098 ± 1,862 | 0.058 | ||||||
| C-reactive protein (mg/l) | 53 | 7.1 ± 6.7 | 7.1 ± 7.5 | 0.0 ± 3.9 | 46 | 7.7 ± 6.1 | 6.7 ± 7.6 | −1.1 ± 6.3 | 0.522 | ||||||
Data are means ± SD.
Changes in lipid parameters are listed as mean percentage change from baseline.