Table 2.
Adverse events summary, specific AEs by system organ class (SOC) with incidence ≥5% in ≥1 treatment group, and incidences of symptomatic hypoglycemia during the 24-week double-blind period in the overall population and for each background AHA stratum
| Patients, n (%) | Sulfonylurea | Glinide | Biguanide | Thiazolidinedione | α-Glucosidase inhibitor | Overall | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Omarigliptin n = 126 | Placebo n = 63 | Omarigliptin n = 65 | Placebo n = 34 | Omarigliptin n = 66 | Placebo n = 33 | Omarigliptin n = 65 | Placebo n = 34 | Omarigliptin n = 67 | Placebo n = 32 | Omarigliptin n = 389 | Placebo n = 196 | |
| With one or more | ||||||||||||
| AEs | 75 (59.5) | 38 (60.3) | 35 (53.8) | 18 (52.9) | 36 (54.5) | 21 (63.6) | 39 (60.0) | 18 (52.9) | 34 (50.7) | 17 (53.1) | 219 (56.3) | 112 (57.1) |
| Drug-relateda AEs | 9 (7.1) | 5 (7.9) | 5 (7.7) | 2 (5.9) | 3 (4.5) | 0 (0.0) | 4 (6.2) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 21 (5.4) | 8 (4.1) |
| Serious AEsb | 2 (1.6) | 0 (0.0) | 1 (1.5) | 1 (2.9) | 1 (1.5) | 1 (3.0) | 4 (6.2) | 0 (0.0) | 0 (0.0) | 2 (6.3) | 8 (2.1) | 4 (2.0) |
| Serious drug-relateda AEs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Who died | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Who discontinued due to | ||||||||||||
| An AE | 0 (0.0) | 0 (0.0) | 2 (3.1) | 1 (2.9) | 0 (0.0) | 0 (0.0) | 2 (3.1) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 4 (1.0) | 2 (1.0) |
| A drug-relateda AE | 0 (0.0) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) |
| A serious AE | 0 (0.0) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 2 (0.5) | 1 (0.5) |
| A serious drug-relateda AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| With specific AEs with incidence ≥5% in ≥1 treatment group, by SOCc | ||||||||||||
| Gastrointestinal disorders | ||||||||||||
| Dental caries | 4 (3.2) | 1 (1.6) | 1 (1.5) | 0 (0.0) | 0 (0.0) | 2 (6.1) | 2 (3.1) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 8 (2.1) | 3 (1.5) |
| Infections and infestations | ||||||||||||
| Bronchitis | 3 (2.4) | 1 (1.6) | 0 (0.0) | 3 (8.8) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 2 (5.9) | 2 (3.0) | 0 (0.0) | 6 (1.5) | 6 (3.1) |
| Gastroenteritis | 2 (1.6) | 0 (0.0) | 0 (0.0) | 2 (5.9) | 4 (6.1) | 0 (0.0) | 1 (1.5) | 1 (2.9) | 0 (0.0) | 0 (0.0) | 7 (1.8) | 3 (1.5) |
| Gingivitis | 2 (1.6) | 1 (1.6) | 0 (0.0) | 0 (0.0) | 2 (3.0) | 0 (0.0) | 0 (0.0) | 2 (5.9) | 0 (0.0) | 0 (0.0) | 4 (1.0) | 3 (1.5) |
| Influenza | 2 (1.6) | 1 (1.6) | 0 (0.0) | 1 (2.9) | 0 (0.0) | 0 (0.0) | 3 (4.6) | 2 (5.9) | 1 (1.5) | 0 (0.0) | 6 (1.5) | 4 (2.0) |
| Nasopharyngitis | 15 (11.9) | 15 (23.8) | 14 (21.5) | 7 (20.6) | 11 (16.7) | 9 (27.3) | 11 (16.9) | 5 (14.7) | 13 (19.4) | 8 (25.0) | 64 (16.5) | 44 (22.4) |
| Pharyngitis | 2 (1.6) | 1 (1.6) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 2 (6.1) | 0 (0.0) | 1 (2.9) | 1 (1.5) | 0 (0.0) | 4 (1.0) | 4 (2.0) |
| Investigations | ||||||||||||
| Alanine aminotransferase increased | 0 (0.0) | 0 (0.0) | 2 (3.1) | 0 (0.0) | 2 (3.0) | 2 (6.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (1.0) | 2 (1.0) |
| Metabolism and nutrition disorders | ||||||||||||
| Hyperglycemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.9) | 0 (0.0) | 2 (6.3) | 0 (0.0) | 3 (1.5) |
| Hypoglycemia | 7 (5.6) | 3 (4.8) | 1 (1.5) | 0 (0.0) | 3 (4.5) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 12 (3.1) | 3 (1.5) |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Myalgia | 0 (0.0) | 1 (1.6) | 1 (1.5) | 1 (2.9) | 0 (0.0) | 3 (9.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.3) | 5 (2.6) |
| Respiratory, thoracic, and mediastinal disorders | ||||||||||||
| Upper respiratory tract inflammation | 0 (0.0) | 0 (0.0) | 1 (1.5) | 2 (5.9) | 0 (0.0) | 1 (3.0) | 1 (1.5) | 0 (0.0) | 1 (1.5) | 1 (3.1) | 3 (0.8) | 4 (2.0) |
| With one or more AE of symptomatic hypoglycemiad | 6 (4.8) | 2 (3.2) | 1 (1.5) | 0 (0.0) | 2 (3.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 9 (2.3) | 2 (1.0) |
| Between-group difference in percentage (omarigliptin − placebo) | 1.6 (−6.5, 7.5) | – | 1.5 (−8.8, 8.3) | – | 3.0 (−7.6, 10.4) | – | 0.0 (−10.2, 5.6) | – | 0.0 (−10.8, 5.5) | – | 1.3 (−1.5, 3.5) | – |
aAssessed by the investigator to be related to the drug
bAfter database lock for the 24-week double-blind period, additional information for the non-serious AE of “cataract” in the omarigliptin group was reported. The new information included that this patient was hospitalized for “cataract” which changed this AE from non-serious to serious. Therefore this patient was not counted as “with serious adverse event” in this table. The change is reflected in the long-term analysis table
cSystem organ class defined by the Medical Dictionary for Regulatory Activities (MedDRA) classification system
dPrespecified AE of interest; symptomatic hypoglycemia: episode with clinical symptoms consistent with hypoglycemia, without regard to glucose level