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. 2015 Nov 18;6(4):573–591. doi: 10.1007/s13300-015-0142-y

Table 3.

Results from the main analysis: 4-arm model with 56 patients in the basal–bolus arm

(a) Estimated end-of-trial HbA1c values, changes from baseline to end-of-treatment per treatment arm, and daily basal insulin dose at end of treatment, based on ANCOVA model
IDegLira (N = 199) GLP-1RA add-on to basal insulin (N = 225) Basal–bolus with insulin glargine as basal component (N = 56) Basal-only (up-titrated insulin glargine) (N = 329)
Mean (SD) 95% CI Mean (SD) 95% CI Mean (SD) 95% CI Mean (SD) 95% CI
EOT HbA1c (%) 6.74 (0.94) (6.60; 6.88) 7.09 [0.94) (6.94; 7.24) 7.04 (0.94) (6.78; 7.29) 7.39 (0.94) (7.28; 7.49)
ΔHbA1c (%) −1.68 (0.94) (−1.82; −1.54) −1.33** (0.94) (−1.48; −1.18) −1.39* (0.94) (−1.64; −1.13) −1.03** (0.94) (−1.14; −0.93)
ΔHbA1c (mmol/mol)a −18 (11) (−20; −17) −15** (13) (−16; −13) −15* (11) (−18; −12) −11** (11) (−12; −10)
Δbody weight (kg) −2.88 (3.42) (−3.39; −2.37) −3.53 (3.42) (−4.08; −2.97) 4.01** (3.42) (3.10; 4.93) 1.16** (3.42) (0.78; 1.55)
ΔBMI (kg/m2) −1.02 (1.21) (–1.19; −0.84) −1.27 (1.21) (−1.47; −1.08) 1.42** (1.21) (1.10; 1.75) 0.43** (1.21) (0.29; 0.56)
ΔSBP (mmHg) −6.84 (12.95) (−8.76; −4.92) −4.68 (12.95) (−6.75; −2.61) 1.83** (12.95) (−1.64; 5.30) −3.47** (12.95) (−4.92; −2.01)
Δtotal cholesterol (mg/dL) −10.44 (29.67) (−14.84; −6.05) −13.26 (29.67) (−18.02; −8.50) −5.80 (29.67) (−13.76; 2.15) −2.88** (29.67) (−6.24; 0.48)
ΔLDL cholesterol (mg/dL) −7.56 (24.07) (−11.12; −3.99) −9.86 (24.07) (−13.73; −5.98) −3.13 (24.07) (−9.58; 3.32) −2.73* (24.07) (−5.45; −0.01)
ΔHDL cholesterol (mg/dL) 0.47 (6.74) (−0.53; 1.47) −0.74 (6.74) (−1.82; 0.34) 0.40 (6.74) (−1.41; 2.20) 1.06 (6.74) (0.30; 1.82)
Δtriglycerides (mg/dL) −18.61 (78.66) (−30.29; −6.92) −16.56 (78.66) (−29.17; −3.94) −16.14 (78.66) (−37.22; 4.93) −9.43 (78.66) (−18.39; −0.47)
EOT daily basal dose (U) 37.80 (27.05)b (33.79; 41.80) 36.63 (27.05)c (32.33; 40.93) 62.43** (27.05)d (55.19; 69.68) 60.65* (27.05) (57.59; 63.72)
(b) Estimated end-of-treatment differences for IDegLira versus comparators, and daily insulin dose at end of treatment, based on ANCOVA model
IDegLira versus GLP-1RA add-on to basal insulin IDegLira versus basal–bolus with insulin glargine as basal component IDegLira versus basal-only (up-titrated insulin glargine)
Mean 95% CI P value Mean 95% CI P value Mean 95% CI P value
ΔHbA1c(%) −0.35 (−0.56; −0.14) 0.0009 −0.30 (−0.58; −0.01) 0.040 −0.65 (−0.83; −0.47) <0.0001
ΔHbA1c (mmol/mol)a −4 (−6; −2) 0.0009 −3 (−6; 0) 0.040 −7 (−9; −5) <0.0001
Δbody weight (kg) 0.65 (−0.11; 1.40) 0.092 −6.89 (−7.92; −5.86) <0.0001 −4.04 (−4.69; −3.40) <0.0001
ΔBMI (kg/m2) 0.26 (−0.01; 0.52) 0.058 −2.44 (−2.80; −2.07) <0.0001 −1.44 (−1.67; −1.21) <0.0001
ΔSBP (mmHg) −2.16 (−5.01; 0.69) 0.14 −8.67 (−12.58; −4.77) <0.0001 −3.37 (−5.80; −0.94) 0.0065
Δtotal cholesterol (mg/dL) 2.82 (−3.71; 9.34) 0.40 −4.64 (−13.60; 4.31) 0.31 −7.56 (−13.16; −1.97) 0.0081
ΔLDL cholesterol (mg/dL) 2.30 (−3.00; 7.60) 0.39 −4.43 (−11.68; 2.83) 0.23 −4.82 (−9.35; −0.30) 0.037
ΔHDL cholesterol (mg/dL) 1.21 (−0.27; 2.70) 0.11 0.07 (−1.96; 2.10) 0.94 −0.59 (−1.86; 0.67) 0.36
Δtriglycerides (mg/dL) −2.05 (−19.36; 15.26) 0.82 −2.46 (−26.20; 21.27) 0.84 −9.18 (−24.10; 5.74) 0.23
Daily basal dose EOT (U) 1.17 (−4.75; 7.09) 0.70 −24.64 (−32.79; −16.49) <0.0001 −22.86 (−27.94; −17.78) <0.0001

IDegLira significantly different: * P < 0.05, ** P < 0.01 (for exact values see Table 3b). Reported SDs are model based

Δ change from baseline, ANCOVA analysis of covariance, BMI body mass index, CI confidence interval, EOT end of treatment, GLP-1RA glucagon-like peptide-1 receptor agonist, HbA 1c glycated hemoglobin, HDL high-density lipoprotein, IDegLira insulin degludec/liraglutide, LDL low-density lipoprotein, SBP systolic blood pressure, SD standard deviation

aCalculated values

bDaily GLP-1RA dose at end of treatment was 1.36 mg (one dose step of IDegLira = 1 U insulin degludec + 0.036 mg liraglutide)

cDaily GLP-1RA dose at end of treatment was 1.8 mg

dDaily bolus dose at end of treatment was 53.60 U. Basal/bolus dose split: 53.8%/46.2%