Table 2.
Primary, secondary, and post-hoc exploratory outcomes at 1 year
| 14-day full-dose group (n=207) | 14-day low-dose group (n=102) | 6-day full-dose group (n=106) | Placebo group (n=98) | p value* | |
|---|---|---|---|---|---|
|
Primary outcomes
| |||||
| Composite of HbA1c <6·5% and insulin dose <0·5 U/kg per day | 19·8% (n=41) | 13·7% (n=14) | 20·8% (n=22) | 20·4% (n=20) | 0·904 |
| Change in HbA1c from baseline (%) | −0·41% (2·3) | −0·33% (2·2) | −0·36% (2·1) | −0·40% (2·7) | 0·659 |
|
| |||||
|
Secondary outcomes
| |||||
| Change in AUC of C-peptide from baseline (nmol/L per min) | −0·06 (0·36) | −0·14 (0·30) | −0·07 (0·39) | −0·09 (0·42) | 0·382 |
| Composite of HbA1c <7% and insulin dose <0·5 U/kg per day | 29·0% (n=60) | 20·6% (n=21) | 26·4% (n=28) | 24·5% (n=24) | 0·404 |
|
| |||||
|
Post-hoc exploratory outcomes
| |||||
| HbA1c (%) | 7·9% (2·3) | 8·0% (2·2) | 7·7% (1·9) | 7·8% (2·4) | 0·978 |
| Change in insulin use from baseline (U/kg per day) | −0·04 (0·58); −0·07 (0·38)† | −0·07 (0·35) | −0·02 (0·35) | 0·01 (0·31) | 0·601 |
| Median change in AUC of C-peptide from baseline (nmol/L per min; IQR) | −0·06 (−0·25 to 0·12) | −0·13 (−0·33 to 0·01) | −0·08 (−0·31 to 0·11) | −0·14 (−0·30 to 0·02) | 0·046 |
| Composite of HbA1c <7·0% and insulin dose <0·25 U/kg per day | 13·0%(n=27) | 8·8% (n=9) | 9·4% (n=10) | 3·1% (n=3) | 0·006 |
Data are percentage (n) or mean (SD), unless otherwise indicated. HbA1C=glycated haemoglobin A1C. AUC=area under the curve.
*
14-day full-dose group versus placebo group.
†
Excludes one outlier with insulin use of 8·5 U/kg per day.