Table 2.
Effect of liraglutide treatment on glycemic control, body weight, insulin dose, blood pressure, glucagon, FFA, and CRP concentrations
| Change over 12 weeks |
P (vs. placebo) |
||||||
|---|---|---|---|---|---|---|---|
| Placebo | 0.6 mg | 1.2 mg | 1.8 mg | 0.6 mg | 1.2 mg | 1.8 mg | |
| Average glucose, mmol/L (mg/dL) (CGMS) | 0.04 ± 0 (0.72 ± 0) | −0.01 ± 0.11 (0.18 ± 1.9) | −0.55 ± 0.11 (10 ± 2)* | −0.55 ± 0.05 (10 ± 1)* | 0.51 | <0.001 | <0.001 |
| HbA1c, % (mmol/mol) | −0.3 ± 0.15 (−3.3 ± 1.6)* | −0.26 ± 0.17 (−2.8 ± 1.9) | −0.78 ± 0.15 (−8.5 ± 1.6)* | −0.42 ± 0.15 (−4.6 ± 1.6)* | 0.81 | <0.01 | 0.39 |
| Glucose SD (CGMS), mmol/L (mg/dL) | −0.02 ± 0.04 (0 ± 1) | −0.04 ± 0.03 (1 ± 0) | −0.23 ± 0.04 (4 ± 1) | −0.12 ± 0.04 (2 ± 1) | 0.65 | <0.01 | 0.13 |
| Total insulin dose (units) | −1.9 ± 0.7 | −2.8 ± 0.7 | −12.1 ± 0.7* | −10.0 ± 0.5* | 0.76 | <0.001 | <0.001 |
| Basal insulin dose (units) | 0.4 ± 0.4 | −1.4 ± 0.3 | −6.3 ± 0.4 | −1.7 ± 0.3 | <0.01 | <0.001 | <0.001 |
| Bolus insulin dose (units) | −1.5 ± 0.4 | −1.4 ± 0.5 | −6.1 ± 0.6 | −8.2 ± 0.3* | 0.87 | <0.001 | <0.001 |
| % time spent at BG concentrations (CGMS) | |||||||
| <3.05 mmol/L (55 mg/dL) | −0.2 ± 0.2 | 0.7 ± 0.3 | 1.0 ± 0.3 | 1.3 ± 0.2 | <0.01 | <0.01 | <0.001 |
| 3.05–3.88 mmol/L (55–70 mg/dL) | −1.0 ± 0.2 | 0.1 ± 0.3 | 1.2 ± 0.4 | 1.1 ± 0.2 | <0.01 | <0.001 | <0.001 |
| 3.8–8.8 mmol/L (70–160 mg/dL) | 1.4 ± 0.6 | −1.1 ± 0.8 | 2.7 ± 0.7 | 4.8 ± 0.8 | <0.05 | 0.19 | <0.01 |
| 8.8–13.3 mmol/L (160–240 mg/dL) | −0.6 ± 0.5 | 0.5 ± 0.6 | −3.5 ± 0.7* | −3.8 ± 0.5* | 0.13 | <0.001 | <0.001 |
| 13.3–22.25 mmol/L (240–400 mg/dL) | 0.8 ± 0.7 | 0.8 ± 0.6 | −2.1 ± 0.9 | −3.5 ± 0.5 | 1.00 | <0.05 | <0.001 |
| Episodes of hypoglycemia/total number of SMBG readings (incidence %)¶ | |||||||
| <3.05 mmol/L (55 mg/dL) | 14/419 (3) | 21/495 (5) | 21/426 (4) | 14/472 (2) | 0.47 | 0.82 | 0.65 |
| 3.05–3.88 mmol/L (55–70 mg/dL) | 21/419 (5) | 35/495 (7) | 24/426 (5) | 27/472 (5) | 0.61 | 0.85 | 0.74 |
| Number of patients with hypoglycemia/total number of patients¶ | |||||||
| <3.05 mmol/L (55 mg/dL) | 14/17 | 13/14 | 16/16 | 13/16 | 0.76 | 0.42 | 0.85 |
| 3.05–3.88 mmol/L (55–70 mg/dL) | 16/17 | 14/14 | 16/16 | 16/16 | 0.86 | 0.89 | 0.91 |
| Carbohydrate intake (g) | −13.4 ± 2.6 | −23.7 ± 2.5 | −47.6 ± 2.6* | −46.4 ± 1.6* | <0.01 | <0.001 | <0.001 |
| Daily carbohydrate helpings (meals per day) | 0.0 ± 0.6 | −0.3 ± 0.2 | −0.9 ± 0.3* | −0.4 ± 0.1 | 0.14 | <0.001 | <0.001 |
| Body weight (kg) | −0.3 ± 0.5 | −2.7 ± 0.6* | −5.0 ± 1.2* | −4.8 ± 0.7* | <0.05 | <0.01 | <0.001 |
| BMI (kg/m2) | −0.1 ± 0.2 | −1.1 ± 0.4* | −1.7 ± 0.5* | −1.5 ± 0.3* | <0.05 | <0.01 | <0.001 |
| SBP (mmHg)† | −0.5 ± 0.7 | −3.0 ± 1.1 | −1.5 ± 1.0 | −3.3 ± 1.1* | 0.07 | 0.89 | <0.05 |
| DBP (mmHg) | 0.9 ± 0.5 | 0.5 ± 0.70 | −0.1 ± 0.4 | −1.0 ± 0.7 | 0.52 | 0.34 | 0.053 |
| Pulse rate | 0 ± 2 | −1 ± 3 | 2.0 ± 1 | 2 ± 2 | 0.62 | 0.48 | 0.43 |
| Glucagon (ng/L) | 5 ± 3 | 7 ± 4 | −6 ± 9 | 9 ± 6 | 0.57 | 0.38 | 0.66 |
| GLP-1 (pmol/L) | 5 ± 7 | 5 ± 2 | 7 ± 5 | 13 ± 4* | 0.52 | 0.44 | 0.17 |
| GIP (pg/mL) | −10 ± 8 | 22 ± 21 | 39 ± 13* | 38 ± 11* | 0.27 | <0.05 | <0.05 |
| FFA (mmol/L) | 0.03 ± 0.03 | 0.05 ± 0.04 | 0.02 ± 0.02 | −0.1 ± 0.03* | 0.54 | 0.88 | <0.05 |
| CRP (g/L) | −0.14 ± 0.11 | −0.21 ± 0.15 | −0.48 ± 0.15* | −0.96 ± 0.19* | 0.41 | <0.05 | <0.05 |
Data are means ± SEM unless otherwise indicated. DBP, diastolic blood pressure.
*P < 0.05 for change compared with baseline within group (paired t test).
¶χ2 test for comparison.
†Two normotensive subjects in 1.8-mg group taking ACE inhibitors for renal protection had to stop or reduce the dose of the drugs because of a fall in SBP to <100 mmHg. Two known hypertensive subjects in this group also had the doses of ACE inhibitor and β-blocker reduced because of a fall in SBP. In the 0.6-mg group, in one normotensive patient the dose of valsartan was reduced to 160 mg from 320 mg at day 56 and to 80 mg at day 70 owing to fall in SBP from 112 to 100 mmHg.