Table 3.
Treatment effects on glucose, HbA1c, insulin, HOMA-IR, NEFA and insulin sensitivity index for lipolysis
| Variable | Placebo (n = 20) | OM-3CA (n = 14) | Dapagliflozin (n = 20) | OM-3CA + dapagliflozin (n = 19) |
|---|---|---|---|---|
| HbA1ca | ||||
| Baseline, mmol/mol | 57.9 (9.0) | 57.3 (8.4) | 56.7 (6.1) | 58.9 (8.9) |
| Baseline, % | 7.44 (0.80) | 7.38 (0.68) | 7.38 (0.56) | 7.50 (0.76) |
| Change, mmol/mol | −0.99 (3.81) | 1.43 (4.35) | −6.89 (7.24) | −4.88 (5.25) |
| Change, % units | −0.09 (0.35) | 0.13 (0.40) | −0.63 (0.66) | −0.45 (0.48) |
| GMR | 0.99 (0.97, 1.01) | 1.01 (0.98, 1.04) | 0.91 (0.87, 0.96)* | 0.94 (0.92, 0.97) |
| Fasting glucose, mmol/l | ||||
| Baseline | 9.40 (1.65) | 9.02 (1.48) | 8.99 (1.85) | 9.38 (1.97) |
| Change | 0.37 (0.82) | 0.21 (1.07) | −0.98 (1.49) | −0.91 (2.00) |
| GMR | 1.04 (0.99, 1.08) | 1.02 (0.95, 1.09) | 0.90 (0.84, 0.96)* | 0.91 (0.83, 1.01)* |
| Fasting insulin, pmol/l | ||||
| Baseline | 72.5 (40.0) | 94.9 (39.2) | 79.1 (38.5) | 75.2 (28.3) |
| Change | −3.8 (18.3) | −4.0 (15.8) | −9.6 (24.6) | −10.7 (22.6) |
| GMR | 0.94 (0.82, 1.07) | 0.96 (0.84, 1.09) | 0.84 (0.72, 0.98) | 0.81 (0.71, 0.93) |
| HOMA-IRb | ||||
| Baseline | 4.2 (2.4) | 5.4 (2.9) | 4.3(1.9) | 4.4 (1.7) |
| Change | −0.19 (1.44) | 0.31 (2.39) | −1.08 (1.38) | −0.86 (1.58) |
| GMR | 0.97 (0.84, 1.12) | 1.03 (0.83, 1.28) | 0.72 (0.60, 0.86)* | 0.76 (0.65, 0.90)* |
| 120 min glucosec, mmol/l | ||||
| Baseline | 17.5 (3.8) | 16.9 (2.2) | 17.2 (4.1) | 16.8 (3.8) |
| Change | 0.7 (1.9) | 0.4 (0.8) | −2.2 (3.1) | −1.2 (2.2) |
| GMR | 1.06 (0.99, 1.12) | 1.02 (0.99, 1.06) | 0.88 (0.78, 0.98)* | 0.94 (0.88, 1.01)* |
| NEFA, mmol/l | ||||
| Baseline | 0.76 (0.34) | 0.64 (0.16) | 0.64 (0.20) | 0.66 (0.18) |
| Change | −0.08 (0.18) | 0.02 (0.14) | 0.04 (0.18) | 0.02 (0.17) |
| GMR | 0.91 (0.80, 1.03) | 1.00 (0.84, 1.20) | 1.07 (0.92, 1.23) | 1.03 (0.90, 1.18) |
| Insulin sensitivity index for lipolysisd | ||||
| Baseline | 0.79 (0.261) | 0.64 (0.238) | 0.79 (0.260) | 0.79 (0.251) |
| Change | 0.027 (0.123) | 0.010 (0.171) | −0.022 (0.124) | 0.027 (0.149) |
| GMR | 1.04 (0.96, 1.13) | 1.04 (0.90, 1.19) | 0.99 (0.90, 1.08) | 1.05 (0.94, 1.16) |
Baseline and change are reported as mean (SD)
Descriptive GMR reported with 95% CIs
Change is change from baseline to end of treatment
aHbA1c: mmol/mol, International Federation of Clinical Chemistry (IFCC); %, National Glycohemoglobin Standardization Program (NGSP) units
bHOMA-IR is calculated as: glucose, mmol/l × insulin, pmol/l)/156
cGlucose levels at 120 min during the OGTT, as a measure of glucose tolerance
dData are derived from measurements of insulin and NEFA at 0, 60 and 120 min during the OGTT
*p < 0.05 vs placebo, mixed model analysis