Table 1.
Cohort 1 | Cohort 2 | ||||||||
---|---|---|---|---|---|---|---|---|---|
IMPACT® | Humana® | ||||||||
DET-S | GLA-C | P | DET-S | GLA-C | P | GLA-S | DET-C | P | |
n = 536 | n = 2,668 | n = 256 | n = 1,262 | n = 419 | n = 780 | ||||
Demographics | |||||||||
Women, n (%) | 262 (48.9) | 1,251 (46.9) | 0.3993 | 143 (55.9) | 692 (54.8) | 0.7636 | 222 (53.0) | 388 (49.7) | 0.2847 |
Age, years, mean (SD) | 53.8 (11.7) | 53.5 (11.8) | 0.6334 | 72.6 (5.4) | 73.0 (5.6) | 0.4089 | 60.9 (11.7) | 60.8 (11.8) | 0.9408 |
Region, n (%) | |||||||||
North East | 123 (22.9) | 608 (22.8) | 0.9361 | 1 (0.4) | 6 (0.5) | 0.8551 | 41 (9.8) | 72 (9.2) | 0.7541 |
South | 287 (53.5) | 1,422 (53.3) | 0.9169 | 212 (82.8) | 1,053 (83.4) | 0.8063 | 319 (76.1) | 587 (75.3) | 0.7361 |
Mid-West | 52 (9.7) | 262 (9.8) | 0.9328 | 24 (9.4) | 110 (8.7) | 0.7348 | 30 (7.2) | 64 (8.2) | 0.5209 |
West | 74 (13.8) | 375 (14.1) | 0.8793 | 19 (7.4) | 91 (7.2) | 0.9054 | 29 (6.9) | 57 (7.3) | 0.8047 |
Clinical characteristics | |||||||||
Baseline HbA1c, %, mean (SD) | 8.7 (1.7) | 8.6 (1.7) | 0.8143 | 8.3 (1.5) | 8.2 (1.5) | 0.5538 | 9.1 (1.9) | 8.9 (1.8) | 0.1124 |
Patients with baseline and follow-up HbA1c data available, n (%) | 282 (52.6) | 1,393 (52.2) | 185 (72.3) | 919 (72.8) | 277 (66.1) | 497 (63.7) | |||
CCI, mean (SD) | 0.7 (1.2) | 0.7 (1.2) | 0.9376 | 2.5 (2.3) | 2.5 (2.3) | 0.941 | 1.33 (1.63) | 1.31 (1.80) | 0.8508 |
Comorbidities, n (%) | |||||||||
Hypertension | 352 (65.7) | 1,836 (68.8) | 0.1535 | 230 (89.8) | 1,120 (88.7) | 0.6104 | 350 (83.5) | 632 (81.1) | 0.2824 |
Hyperlipidemia | 373 (69.6) | 1,837 (68.9) | 0.7366 | 207 (80.9) | 1,024 (81.1) | 0.9164 | 349 (83.3) | 640 (82.1) | 0.5895 |
Neuropathy | 91 (17.0) | 490 (18.4) | 0.4465 | 111 (43.3) | 514 (40.7) | 0.4356 | 105 (25.1) | 186 (23.8) | 0.6403 |
Nephropathy | 40 (7.5) | 222 (8.3) | 0.5082 | 101 (39.5) | 501 (39.7) | 0.9416 | 85 (20.3) | 137 (17.6) | 0.2472 |
Retinopathy | 103 (19.2) | 501 (18.8) | 0.8128 | 57 (22.3) | 305 (24.2) | 0.5149 | 72 (17.2) | 138 (17.7) | 0.8252 |
Obesity | 71 (13.2) | 287 (10.8) | 0.0951 | 50 (19.5) | 248 (19.7) | 0.9648 | 60 (14.3) | 110 (14.1) | 0.9181 |
Number of OADs, n (SD) | 1.09 (1.09) | 1.05 (1.06) | 0.4840 | 0.93 (0.89) | 0.92 (0.87) | 0.9023 | 1.16 (1.01) | 1.14 (0.95) | 0.6404 |
Metformin | 254 (47.4) | 1,209 (45.3) | 0.3792 | 95 (37.1) | 503 (39.9) | 0.412 | 211 (50.4) | 423 (54.2) | 0.2002 |
Sulfonylurea | 127 (23.7) | 704 (26.4) | 0.1943 | 103 (40.2) | 476 (37.7) | 0.4498 | 166 (39.6) | 290 (37.2) | 0.4069 |
Thiazolidinedione | 119 (22.2) | 546 (20.4) | 0.3656 | 31 (12.1) | 141 (11.2) | 0.6664 | 52 (12.4) | 88 (11.3) | 0.5618 |
Alpha-glucosidase | 2 (0.4) | 16 (0.6) | 0.5219 | 2 (0.8) | 7 (0.6) | 0.6668 | 2 (0.5) | 3 (0.4) | 0.8122 |
Dipeptidyl peptidase-4 inhibitor | 60 (11.2) | 238 (8.9) | 0.0982 | 1 (0.4) | 5 (0.4) | 0.9897 | 45 (10.7) | 71 (9.1) | 0.3605 |
Meglitinide | 21 (3.9) | 95 (3.6) | 0.6862 | 6 (2.3) | 32 (2.5) | 0.8587 | 12 (2.9) | 12 (1.5) | 0.1182 |
Glucagon-like peptide-1 analog | 57 (10.6) | 314 (11.8) | 0.4537 | 2 (0.8) | 9 (0.7) | 0.9068 | 25 (6.0) | 58 (7.4) | 0.3392 |
RAI use, n (%) | 261 (48.7) | 1,311 (49.1) | 0.8512 | 87 (34.0) | 438 (34.7) | 0.8246 | 176 (42.0) | 332 (42.6) | 0.8518 |
Glargine (Cohort 1) and Detemir (Cohort 2) DACON, IU, mean (SD) | 45.1 (29.3) | 46.6 (30.9) | 0.2913 | 40.0 (22.6) | 41.1 (26.1) | 0.4932 | 51.2 (38.1) | 49.3 (39.1) | 0.4381 |
Type of baseline insulin device: vial users, n (%) | 387 (72.2) | 1,913 (71.7) | 0.8145 | 208 (81.3) | 982 (77.8) | 0.2231 | 134 (32.0) | 280 (35.9) | 0.1738 |
Any hypoglycemia, n (%) event rate (# events/person/year) | 37 (6.9) 0.15 (0.76) | 189 (7.1) 0.16 (1.19) | 0.8813 0.7808 | 26 (10.2) 0.21 (1.01) | 101 (8.0) 0.14 (0.63) | 0.2566 0.2710 | 29 (6.9) 0.10 (0.51) | 53 (6.8) 0.21 (2.81) | 0.9341 0.3229 |
Inpatient/ED-related hypoglycemia, n (%) event rate (# events/person/year) | 16 (3.0) 0.04 (0.21) | 74 (2.8) 0.04 (0.27) | 0.7869 0.9556 | 13 (5.1) 0.06 (0.29) | 46 (3.6) 0.05 (0.27) | 0.2794 0.3596 | 11 (2.6) 0.03 (0.23) | 25 (3.2) 0.04 (0.23) | 0.5748 0.7871 |
Economic characteristics | |||||||||
Any hospitalization, n (%) | 63 (11.8) | 325 (12.2) | 0.7818 | 55 (21.5) | 300 (23.8) | 0.4305 | 75 (17.9) | 129 (16.5) | 0.5498 |
Diabetes-related hospitalization, n (%) | 59 (11.0) | 290 (10.9) | 0.9255 | 46 (18.0) | 271 (21.5) | 0.2084 | 65 (15.5) | 113 (14.5) | 0.6338 |
Total costs, $, mean (SD) | 11,161 (17,431) | 11,051 (19,793) | 0.8964 | 9,701 (21,747) | 8,633 (12,339) | 0.4470 | 10,460 (18,301) | 9,866 (15,112) | 0.5702 |
Total diabetes-related cost, $, mean (SD) | 4,861 (7,033) | 4,975 (9,242) | 0.7464 | 4,260 (7,215) | 4,507 (7,537) | 0.6295 | 4,751 (6,648) | 4,788 (7,411) | 0.9291 |
Standardized differences were <10 for all group comparisons
CCI Charlson Comorbidity Index, DACON daily average consumption, DET-C patients continuing on insulin detemir, DET-S patients switching from insulin glargine to insulin detemir, ED emergency department, GLA-S patients switching from insulin detemir to insulin glargine, GLA-C patients continuing on insulin glargine; HbA 1c glycated hemoglobin, OAD oral anti-diabetes drug, RAI rapid acting insulin, SD standard deviation