TABLE 2.
Primary and secondary outcomes at baseline, 12 and 26 weeks of follow-up*
| Outcome | Liraglutide | Glargine | P |
|---|---|---|---|
| HbA1c, % | |||
| 12 weeks (liraglutide, n = 88, 100) | 7.1 ± 1.3 | 7.4 ± 1.2 | 0.04 |
| 26 weeks (liraglutide, n = 80, 93) | 7.13 ± 1.3 | 7.68 ± 1.69 | 0.016 |
| Fasting blood glucose, mmol/L | |||
| 12 weeks (liraglutide, n = 60; insulin glargine, n = 79) | 7.96 ± 3.3 | 7.70 ± 2.6 | 0.40 |
| 26 weeks (liraglutide, n = 53; insulin glargine, n = 60) | 7.61 ± 2.2 | 8.56 ± 3.8 | 0.21 |
| Postprandial blood glucose, mmol/L | |||
| 12 weeks (liraglutide, n = 44; insulin glargine, n = 42) | 7.67 ± 1.6 | 9.32 ± 2.8 | 0.002 |
| 26 weeks | 8.23 ± 2.8 | 8.72 ± 2.3 | 0.21 |
| Body weight change from baseline, kg | |||
| 12 weeks (liraglutide, n = 87; insulin glargine, n = 89) | −1.1 ± 16 | −1.3 ± 7.8 | 0.09 |
| 26 weeks (liraglutide, n = 73; insulin glargine, n = 91) | −4.77 ± 8 | +0.6 ±11 | <0.01 |
| Hypoglycaemia, n (%) | |||
| <3.88 mmol/L, n (%) | 18 (13) | 31 (23) | 0.038 |
| <3.0 mmol/L, n (%) | 1 (1) | 4 (3) | 0.37 |
| <2.2 mmol/L, n (%) | 2 (1) | 3 (2) | 0.68 |
| HbA1c < 7% (53 mmol/mol) without hypoglycaemia, n (%) | |||
| 12 weeks | 40 (48) | 31 (33) | 0.05 |
| 26 weeks | 34 (45) | 29 (33) | 0.14 |
| HbA1c < 7% (53 mmol/mol) without weight gain, n (%) | |||
| 12 weeks | 40 (45) | 24 (25) | 0.005 |
| 26 weeks | 32 (41) | 21 (23) | 0.01 |
| HbA1c < 7% (53 mmol/mol) without hypoglycaemia and no weight gain, n (%) | |||
| 12 weeks | 35 (41) | 23 (24) | 0.02 |
| 26 weeks | 30 (39) | 20 (22) | 0.014 |
| Systolic BP, mm Hg | |||
| At discharge (liraglutide, n = 104; insulin glargine, n = 112) | 134 ± 17 | 130 ± 16 | 0.027 |
| 12 weeks (liraglutide, n = 86; insulin glargine, n = 89) | 135 ± 22 | 134 ± 21 | 0.47 |
| 26 weeks (liraglutide, n = 73; insulin glargine, n = 90) | 136 ± 22 | 134.9 ± 19 | 0.86 |
| Heart rate, beats/min | |||
| At discharge (liraglutide, n = 104; insulin glargine, n = 112) | 79 ± 14 | 79 ± 14 | 0.99 |
| 12 weeks (liraglutide, n = 86; insulin glargine, n = 87) | 82 ± 12 | 77.4 ± 13 | 0.004 |
| 26 weeks (liraglutide, n = 73; insulin glargine, n = 90) | 83 ± 13 | 79 ± 14 | 0.06 |
| Adverse events, n (%) | |||
| Nausea | 37 (46) | 3 (4) | <0.01 |
| Vomiting | 18 (24) | 0 (0) | <0.01 |
| Medication discontinued due to AEs | 13 (10) | 0 (0) | <0.001 |
| Emergency department visit | 31 (23) | 23 (17) | 0.24 |
| Congestive heart failure | 12 (9) | 13 (9) | 0.85 |
| Acute myocardial infarction | 0 (0) | 1 (1) | >0.99 |
| Acute kidney injury | 1 (1) | 3 (2) | 0.62 |
| Cerebrovascular event | 0 (0) | 3 (2) | 0.25 |
| Readmission | 35 (26) | 43 (31) | 0.30 |
| Death | 2 (1) | 1 (1) | 0.62 |
Note: Data are expressed as mean ± SD, unless otherwise indicated.
Abbreviations: AE, adverse event; BP, blood pressure; HbA1c, glycated haemoglobin.