Table 1.
Parameters | Baseline (n = 7) | 3 months (n = 7) | 6 months (n = 7) | p value |
---|---|---|---|---|
Primary end point achieved | – | 4 | 6 | – |
Weight (kg) | 84.5(67.7–87.3) | 82.7(69.6–88.5) | 82.3 (70.1–85.3) | 0.964 |
BMI (kg/m2) | 29.3 (24.6–30.8) | 28.6 (24.9–30.8) | 28.6 (25.3–30.9) | 0.964 |
Insulin requirement (IU/day) | 76.0 (50.0–92.0) | 38.0 (22.0–54.0) | 38.0 (22.0–44.0) | 0.002* |
HbA1c (%) (mmol/mol) | 6.8 (6.4–7.5) | 6.5 (6.2–6.7) | 6.8 (6.6–7.0) | 0.102 |
51.0 (46.0–58.0) | 48.0 (44.0–50.0) | 51.0 (49.0–53.0) | ||
FPG (mmol/L) | 5.8 (5.0–6.2) | 6.6 (5.0–6.76) | 6.6 (6.2–6.6) | 0.018* |
Fasting C-pep (nmol/L) | 0.5 (0.4–0.7) | 0.5 (0.4–0.6) | 0.4 (0.3–0.7) | 0.368 |
Glucagon stimulated C-pep (nmol/L) | 0.9 (0.4–1.3) | 0.7 (0.6–0.9) | 0.8 (0.5–1.0) | 0.867 |
HOMA-IR (%) | 1.2 (0.8–1.7) | 1.3 (0.9–1.5) | 0.9 (0.7–1.8) | 0.565 |
HOMA-β (%) | 69.4 (59.6–107.5) | 60.2 (49.2–78.6) | 52.3 (41.4–77.5) | 0.651 |
HOMA-S (%) | 83.7 (59.0–118.1) | 79.8 (69.0–104.1) | 107.9 (56.0–147.5) | 0.565 |
Hypoglycemic episodes/patient/month | 0.0 (0.0–3.0) | 8.0 (5.0–11.0) | 0.0 (0.0–3.0) | 0.013* |
Mixed meal tolerance test | ||||
Fasting C-peptide (nmol/L) | 0.5 (0.3–0.7) | – | 0.3 (0.2–0.5) | 0.612 |
AUC of C-peptide (nmol/L) | 179.9 (77.4–251.5) | – | 151.9 (123.4–206.8) | 1.000 |
Peak C-peptide (nmol/L) | 1.8 (1.1–3.3) | – | 2.2 (1.6–2.6) | 1.000 |
Hyperglycemic clamp study | ||||
Fasting C-pep (nmol/L) | 0.6 (0.5–0.8) | – | 0.6 (0.4–0.9) | 0.605 |
AUC of 1st-phase C-peptide (nmol/L) | 4.1 (1.9–5.9) | – | 4.5 (2.9–6.8) | 0.553 |
AUC of 2nd-phase C-peptide (nmol/L) | 52.6 (29.1–70.2) | – | 74.0 (35.8–90.1) | 0.018* |
Insulin sensitivity index (µmoles/kg/min/pmol/L) | 0.2 (0.1–0.4) | 0.2 (0.1–0.2) | 0.066 | |
Hyperinsulinemic–euglycemic clamp study | ||||
Glucose disposal rate (mg/kg min) | 2.4 (1.9–2.9) | – | 2.2 (1.9–2.8) | 0.139 |
Insulin sensitivity (mg/kg min/μU/mL) | 3.4 (2.5–6.0) | – | 3.4 (2.6–4.6) | 0.553 |
All values are expressed as median and interquartile range
* Significant difference from baseline