Table 1.
Baseline characteristic | Type 1 diabetes | Type 2 diabetes | ||||||
---|---|---|---|---|---|---|---|---|
Glargine U100 | IDet | NPH | Overall 12 | Glargine U100 | IDet | NPH | Overall 12 | |
Full analysis set, n | 888 | 726 | 53 | 1717 | 259 | 415 | 95 | 833 |
Age, years | 46.5 (15.4) | 49.3 (15.9) | 47.0 (13.3) | 47.7 (15.6)* | 63.9 (10.6) | 65.1 (10.5) | 65.5 (10.1) | 64.6 (10.5)* |
Female/male, % | 45.0/55.0 | 45.7/54.3 | 49.1/50.9 | 45.7/54.3 | 40.5/59.5 | 43.6/56.4 | 44.2/55.8 | 42.4/57.6 |
Weight, kg | 75.8 (16.3) | 78.8 (16.4) | 81.8 (17.7) | 77.4 (16.4) | 93.2 (20.6) | 97.7 (20.4) | 103.3 (22.9) | 97.2 (21.0) |
BMI, kg/m2 | 25.9 (4.6) | 26.6 (4.9) | 27.6 (5.3) | 26.3 (4.8)* | 32.1 (6.1) | 33.8 (6.0) | 35.8 (7.2) | 33.6 (6.3)* |
HbA1c, mmol/mol† | 64 (13) | 64 (14) | 64 (14) | 64 (14) | 68 (15) | 68 (15) | 67 (12) | 68 (15) |
HbA1c, % | 8.0 (1.2) | 8.0 (1.3) | 8.0 (1.3) | 8.0 (1.3) | 8.4 (1.4) | 8.4 (1.4) | 8.3 (1.1) | 8.4 (1.4) |
Fasting plasma glucose, mmol/l† | 8.9 (3.3) | 9.3 (3.7) | 7.8 (3.0) | 9.1 (3.8) | 9.5 (2.6) | 9.7 (2.9) | 11.9 (4.4) | 9.9 (3.0) |
Fasting plasma glucose, mg/dl | 161.3 (59.6) | 167.6 (67.0) | 140.4 (54.7) | 163.4 (68.6) | 172.0 (47.5) | 174.2 (51.6) | 214.5 (79.7) | 178.9 (54.4) |
Type of insulin before insulin degludec initiation, n (%) | ||||||||
Basal only | 1 (0.1) | 0 (0.0) | 0 (0.0) | 1 (0.1) | 67 (25.9) | 94 (22.7) | 22 (23.2) | 187 (22.4) |
Basal + prandial | 887 (99.9) | 726 (100.0) | 53 (100.0) | 1693 (98.6) | 192 (74.1) | 321 (77.3) | 73 (76.8) | 621 (74.5) |
Frequency of basal injections, n (%) | ||||||||
Once daily | 675 (76.0) | 150 (20.7) | 19 (35.8) | 857 (49.9) | 201 (77.6) | 242 (58.3) | 53 (55.8) | 520 (62.4) |
Twice daily or more | 202 (22.7) | 538 (74.1) | 34 (64.2) | 786 (45.8) | 54 (20.8) | 128 (30.8) | 40 (42.1) | 234 (28.1) |
Unknown/missing | 11 (1.2) | 38 (5.2) | 0 (0.0) | 74 (4.3) | 4 (1.5) | 45 (10.8) | 2 (2.1) | 79 (9.5) |
History of diabetes | ||||||||
Duration of diabetes, years | 21.1 (13.5) | 22.9 (13.3) | 17.5 (11.8) | 21.8 (13.5) | 16.7 (8.2) | 17.9 (8.4) | 18.0 (7.1) | 17.5 (8.1) |
Duration of insulin treatment, years | 20.6 (13.6) | 22.3 (13.2) | 16.9 (11.9) | 21.2 (13.5) | 8.5 (5.9) | 9.9 (6.3) | 11.5 (6.8) | 9.7 (6.3) |
Presence of ≥1 ‘at risk for severe hypoglycaemia’ criterion, n (%) | ||||||||
Experienced ≥1 severe hypoglycaemic event within the last year | 105 (11.8) | 68 (9.4) | 5 (9.4) | 181 (10.5)* | 15 (5.8) | 5 (1.2) | – | 21 (2.5)* |
Moderate chronic renal failure | 39 (4.4) | 57 (7.9) | 1 (1.9) | 99 (5.8)* | 38 (14.7) | 52 (12.5) | 19 (20.0) | 117 (14.0)* |
Hypoglycaemic symptom unawareness (history of impaired automatic responses) as judged by the physician | 174 (19.6) | 135 (18.6) | 14 (26.4) | 325 (18.9)* | 34 (13.1) | 22 (5.3) | 5 (5.3) | 61 (7.3)* |
For Type 1 diabetes: duration of diabetes >15 years | 542 (61.0) | 477 (65.7) | 26 (49.1) | 1071 (62.4)* | – | – | – | – |
For Type 2 diabetes: duration of diabetes >5 years | – | – | – | – | 165 (63.7) | 301 (72.5) | 79 (83.2) | 599 (71.9)* |
Glargine U100, insulin glargine 100 units/mL; IDet, insulin detemir; NPH, neutral protamine Hagedorn.
Values are mean (sd) unless otherwise stated. *Not published previously. †Calculated, not measured.