o-treat population
† Severe episodes of hypoglycemia were defined as those where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained)
Overall [N (%)] 5 (2.6) 7 (3.6) 6 (3.0)
In Combination with Metformin(26 weeks) Placebo + Metformin(N=183) INVOKANA 100 mg + Metformin(N=368) INVOKANA 300 mg + Metformin(N=367)
Overall [N (%)] 3 (1.6) 16 (4.3) 17 (4.6)
Severe [N (%)]† 0 (0) 1 (0.3) 1 (0.3)
In Combination with Metformin(52 weeks) Glimepiride + Metformin(N=482) INVOKANA 100 mg + Metformin(N=483) INVOKANA 300 mg + Metformin(N=485)
Overall [N (%)] 165 (34.2) 27 (5.6) 24 (4.9)
Severe [N (%)]† 15 (3.1) 2 (0.4) 3 (0.6)
In Combination with Sulfonylurea(18 weeks) Placebo+ Sulfonylurea(N=69) INVOKANA 100 mg+ Sulfonylurea(N=74) INVOKANA 300 mg+ Sulfonylurea(N=72)
Overall [N (%)] 4 (5.8) 3 (4.1) 9 (12.5)
In Combination with Metformin + Sulfonylurea(26 weeks) Placebo + Metformin + Sulfonylurea(N=156) INVOKANA 100 mg + Metformin+ Sulfonylurea(N=157) INVOKANA 300 mg + Metformin + Sulfonylurea(N=156)
Overall [N (%)] 24 (15.4) 43 (27.4) 47 (30.1)
Severe [N (%)]† 1 (0.6) 1 (0.6) 0
In Combination with Metformin + Sulfonylurea(52 weeks) Sitagliptin + Metformin + Sulfonylurea(N=378) INVOKANA 300 mg + Metformin + Sulfonylurea(N=377)
Overall [N (%)] 154 (40.7) 163 (43.2)
Severe [N (%)]† 13 (3.4) 15 (4.0)
In Combination with Metformin + Pioglitazone(26 weeks) Placebo + Metformin + Pioglitazone(N=115) INVOKANA 100 mg + Metformin + Pioglitazone(N=113) INVOKANA 300 mg + Metformin + Pioglitazone(N=114)
Overall [N (%)] 3 (2.6) 3 (2.7) 6 (5.3)
In Combination with Insulin(18 weeks) Placebo(N=565) INVOKANA 100 mg(N=566) INVOKANA 300 mg(N=587)
Overall [N (%)] 208 (36.8) 279 (49.3) 285 (48.6)
Severe [N (%)]† 14 (2.5) 10 (1.8) 16 (2.7)
Number of patients experiencing at least one event of hypoglycemia based on either biochemically documented episodes or severe hypoglycemic events in the intent-to-treat population
Severe episodes of hypoglycemia were defined as those where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained)
Overall [N (%)] 5 (2.6) 7 (3.6) 6 (3.0)
In Combination with Metformin(26 weeks) Placebo + Metformin(N=183) INVOKANA 100 mg + Metformin(N=368) INVOKANA 300 mg + Metformin(N=367)
Overall [N (%)] 3 (1.6) 16 (4.3) 17 (4.6)
Severe [N (%)]† 0 (0) 1 (0.3) 1 (0.3)
In Combination with Metformin(52 weeks) Glimepiride + Metformin(N=482) INVOKANA 100 mg + Metformin(N=483) INVOKANA 300 mg + Metformin(N=485)
Overall [N (%)] 165 (34.2) 27 (5.6) 24 (4.9)
Severe [N (%)]† 15 (3.1) 2 (0.4) 3 (0.6)
In Combination with Sulfonylurea(18 weeks) Placebo+ Sulfonylurea(N=69) INVOKANA 100 mg+ Sulfonylurea(N=74) INVOKANA 300 mg+ Sulfonylurea(N=72)
Overall [N (%)] 4 (5.8) 3 (4.1) 9 (12.5)
In Combination with Metformin + Sulfonylurea(26 weeks) Placebo + Met |
