Table 3.
Secondary efficacy endpoints after 26 weeks of treatment
| Endpoint | Insulin detemir (n = 20) | NPH insulin (n = 22) |
|---|---|---|
| FPG, mmol/L | 7.66 (2.63) | 7.86 (2.88) |
| Change from baseline | − 0.335 (2.961) | − 2.332 (4.147) |
| Body weight, SDS | 1.538 (0.690) | 1.358 (0.840) |
| Change from baseline | 0.006 (0.192) | 0.098 (0.139) |
| Body weight, kg | 77.79 (16.16) | 77.20 (24.60) |
| Change from baseline | 1.89 (3.40) | 4.00 (3.75) |
| Height, SDS | − 0.129 (1.057) | − 0.185 (1.046) |
| Change from baseline | − 0.042 (0.167) | − 0.019 (0.152) |
| BMI, kg/m2 | 29.09 (4.40) | 28.90 (7.20) |
| Change from baseline | 0.35 (1.22) | 1.20 (1.29) |
| BMI, SDS | 1.694 (0.405) | 1.538 (0.658) |
| Change from baseline | 0.013 (0.176) | 0.086 (0.132) |
| Mean 7-point SMBGa, mmol/L | 8.28 (2.72) | 8.45 (3.06) |
| Patients achieving HbA1c, n (%) | ||
| < 7.0% (< 53 mmol/mol) | 5 (25) | 7 (31.8) |
| < 7.5% (< 58 mmol/mol) | 6 (30) | 8 (36.4) |
| Patients achieving HbA1c < 7.0% (< 53 mmol/mol) without treatment-emergent severe hypoglycemic episodesb, n (%) | 5 (25) | 7 (33.3) |
Data are mean (SD) unless specified
BMI body mass index, FPG fasting plasma glucose, NPH neutral protamine Hagedorn, SDS standard deviation score, SMBG self-measured blood glucose
aMean 7-point SMBG profile is calculated as the arithmetic mean of all 7 points
bWithin the last 14 weeks of treatment and only subjects who had been exposed for minimum 14 weeks included