Table 2.
Participant characteristics (n=253) according to their glycemic change pattern within one year post-insulin initiation†
| Consistent HbA1c decrease of ≥0.5% (A, n=84) | <0.5% change in HbA1c (B, n=117) | Consistent HbA1c increase of ≥0.5% (C, n=52) | P-value | |
|---|---|---|---|---|
| At randomization | ||||
| Female (%) | 63.1% | 66.7% | 57.7% | P=ns |
| Race-ethnicity (%) | ||||
| Non-Hispanic Black | 40.5% | 38.5% | 40.4% | P=ns |
| Hispanic | 39.3% | 34.2% | 40.4% | |
| Non-Hispanic White | 17.9% | 17.9% | 11.5% | |
| Other | 2.4% | 9.4% | 7.7% | |
| Age (years) | 13.5 ± 2.0 | 14.3 ± 2.0 | 14.0 ± 2.1 | P=ns |
| Diabetes duration (months) | 9.7 ± 6.9 | 8.6 ± 6.5 | 8.5 ± 5.5 | P=ns |
| HbA1c (%) | 6.3 ± 0.7 | 6.5 ± 0.8 | 6.4 ± 0.7 | P=ns |
| BMI (kg/m2) | 34.2 ± 6.8 | 35.2 ± 7.7 | 36.2 ± 8.5 | P=ns |
| BMI Z-score | 2.2 ± 0.5 | 2.2 ± 0.5 | 2.3 ± 0.5 | P=ns |
| Total adiponectin (ng/mL)1 | 5979 ± 2541 | 5198 ± 2239 | 5293 ± 2211 | P=0.040 A vs B |
| HMW adiponectin (ng/mL)1 | 3202 ± 1849 | 2770 ± 1744 | 2738 ± 1710 | P=0.046 A vs B,C |
| 1/ fasting insulin (mL/uU) | 0.052 ± 0.036 | 0.043 ± 0.036 | 0.047 ± 0.041 | P=0.020 A vs B |
| oDI | 0.0025 ± 0.0025 | 0.0020 ± 0.0021 | 0.0023 ± 0.0031 | ns |
| At time of glycemic failure (insulin initiation) | ||||
| Diabetes duration (years) | 2.7 ± 1.2 | 2.3 ± 1.1 | 2.4 ± 1.0 | ns |
| HbA1c (%) | 11.1 ± 2.0 | 9.8 ± 1.7 | 9.1 ± 1.4 | P=0.0001 ALL |
| BMI (kg/m2) | 34.1 ± 7.6 | 36.0 ± 7.8 | 36.5 ± 8.5 | P=ns |
| BMI Z-score | 2.0 ± 0.6 | 2.1 ± 0.6 | 2.2 ± 0.6 | P=ns |
| Total adiponectin (ng/mL)1 | 5737 ± 2452 | 5225 ± 3875 | 5241 ± 2204 | P=ns |
| HMW adiponectin (ng/mL)1 | 3025 ± 1973 | 2770 ± 2536 | 2693 ± 1590 | P=ns |
| 1/ fasting insulin (mL/uU)2 | 0.060 ± 0.043 | 0.042 ± 0.035 | 0.045 ± 0.032 | P=0.002 A vs B,C |
| Change from baseline | 0.012 ± 0.035 | 0.001 ± 0.024 | 0.003 ± 0.028 | (P=0.062 A vs B) |
| oDI2 | 0.0012 ± 0.0013 | 0.0009 ± 0.0008 | 0.0012 ± 0.0011 | P=ns |
| Change from baseline | −0.0011 ± 0.0019 | −0.0008 ± 0.0017 | −0.0008 ± 0.0015 | P=ns |
| At one year ± 3 months post-insulin initiation | ||||
| Diabetes duration (years) | 3.5 ± 1.2 | 3.2 ± 1.1 | 3.3 ± 1.0 | P=ns |
| HbA1c (%) | 9.1 ± 2.4 | 9.9 ± 1.9 | 11.5 ± 1.5 | P<0.0001 ALL |
| BMI (kg/m2) | 35.6 ± 7.2 | 35.9 ± 7.2 | 36.1 ± 8.2 | P=ns |
| BMI Z-score | 2.1 ± 0.5 | 2.1 ± 0.6 | 2.0 ± 0.7 | P=ns |
| Total adiponectin (ng/mL)1 | 5970 ± 2532 | 5344 ± 4233 | 5648 ± 1526 | P=ns |
| HMW adiponectin (ng/mL)1 | 3392 ± 1908 | 3139 ± 3943 | 2817 ± 1135 | P=ns |
| Prescribed insulin dose3 (units/kg/day) | 0.8 ± 0.5 | 0.6 ± 0.4 | 0.7 ± 0.5 | P=ns |
| Insulin dose (total daily units)3 | 73.6 ± 47.9 | 65.2 ± 48.7 | 68.8 ± 46.6 | P=ns |
| Type of insulin | ||||
| Glargine only | 54.2% | 65.6% | 60.0% | P=ns |
| Glargine+Humalog | 26.4% | 15.6% | 8.9% | |
| Other insulin | 11.1% | 12.5% | 26.7% | |
| Any combination | 8.3% | 6.3% | 4.4% |
†
HMW: high molecular weight; oDI: c-peptide based oral disposition index;
1
P-value from model adjusted for race/ethnicity;
2
P-value from model adjusted for HbA1c at time of failure;
3
P-value from model adjusted for HbA1c at year 1.