Table 3

AE summary through Week 14

PlaceboMK-0941 dose (mg t.i.d. a.c.)
10203040
n115119117117119
≥1 AEs58 (50.4)73 (61.3)75 (64.1)71 (60.7)73 (61.9)
Drug-related AEs17 (14.8)20 (16.8)36 (30.8)32 (27.4)35 (29.7)
SAEs1 (0.9)4 (3.4)2 (1.7)4 (3.4)4 (3.4)
Drug-related SAEs00001 (0.8)
Discontinued owing to AEs3 (2.6)4 (3.4)3 (2.6)3 (2.6)6 (5.1)
Discontinued owing to drug-related AEs1 (0.9)02 (1.7)1 (0.9)4 (3.4)
Discontinued owing to SAEs1 (0.9)0001 (0.8)
Discontinued owing to drug-related SAEs00001 (0.8)
Specific AEs occurring with an incidence of ≥5% in any group
 Hypoglycemia40 (34.8)46 (38.7)61 (52.1)*54 (46.2)63 (53.4)*
 Cataracts5 (4.3)8 (6.7)1 (0.9)5 (4.3)2 (1.7)
 Diarrhea3 (2.6)6 (5.0)5 (4.3)3 (2.6)3 (2.5)
 Influenza0 (0)6 (5.0)2 (1.7)8 (6.8)4 (3.4)
 Nasopharyngitis1 (0.9)3 (2.5)9 (7.7)3 (2.6)6 (5.1)
 Upper respiratory tract infection2 (1.7)4 (3.4)5 (4.3)7 (6.0)4 (3.4)
 Headache2 (1.7)2 (1.7)10 (8.5)3 (2.6)4 (3.4)
  • Data are n (%). For all end points except for hypoglycemia, this summary includes data after initiation of glycemic rescue therapy. For hypoglycemia, this summary excludes data after initiation of glycemic rescue therapy to eliminate the confounding effect of increased insulin dose. SAE, serious adverse event.

  • †Considered by the investigator to be drug related.

  • *P ≤ 0.01 vs. placebo (analysis of between-group difference relative to placebo was prespecified for hypoglycemia AEs).