ADVERSE REACTIONS
METAGLIP
In a double-blind 24-week clinical trial involving METAGLIP as initial therapy, a total of 172 patients received METAGLIP 2.5 mg/250 mg, 173 received METAGLIP 2.5 mg/500 mg, 170 received glipizide, and 177 received metformin. The most common clinical adverse events in these treatment groups are listed in Table 4.
Table 4: Clinical Adverse Events >5% in any Treatment Group, by Primary Term, in Initial Therapy Study | Number (%) of Patients |
|---|
Adverse Event | Glipizide
5 mg
tablets
N=170 | Metformin
500 mg
tablets
N=177 | METAGLIP
2.5 mg/250 mg
tablets
N=172 | METAGLIP
2.5 mg/500 mg
tablets
N=173 |
|---|
| Upper respiratory infection | 12 (7.1) | 15 (8.5) | 17 (9.9) | 14 (8.1) |
| Diarrhea | 8 (4.7) | 15 (8.5) | 4 (2.3) | 9 (5.2) |
| Dizziness | 9 (5.3) | 2 (1.1) | 3 (1.7) | 9 (5.2) |
| Hypertension | 17 (10.0) | 10 (5.6) | 5 (2.9) | 6 (3.5) |
| Nausea/vomiting | 6 (3.5) | 9 (5.1) | 1 (0.6) | 3 (1.7) |
In a double-blind 18-week clinical trial involving METAGLIP as second-line therapy, a total of 87 patients received METAGLIP, 84 received glipizide, and 75 received metformin. The most common clinical adverse events in this clinical trial are listed in Table 5.
Table 5: Clinical Adverse Events >5% in any Treatment Group, by Primary Term, in Second-Line Therapy Study | Number (%) of Patients |
|---|
Adverse Event | Glipizide
5 mg
tabletsa
N=84 | Metformin
500 mg
tabletsa
N=75 | METAGLIP
5 mg/500 mg
tabletsa
N=87 |
|---|
|
a The dose of glipizide was fixed at 30 mg daily; doses of metformin and METAGLIP were titrated.
|
| Diarrhea | 11 (13.1) | 13 (17.3) | 16 (18.4) |
| Headache | 5 (6.0) | 4 (5.3) | 11 (12.6) |
| Upper respiratory infection | 11 (13.1) | 8 (10.7) | 9 (10.3) |
| Musculoskeletal pain | 6 (7.1) | 5 (6.7) | 7 (8.0) |
| Nausea/vomiting | 5 (6.0) | 6 (8.0) | 7 (8.0) |
| Abdominal pain | 7 (8.3) | 5 (6.7) | 5 (5.7) |
| UTI | 4 (4.8) | 6 (8.0) | 1 (1.1) |
Hypoglycemia
In a controlled initial therapy trial of METAGLIP 2.5 mg/250 mg and 2.5 mg/500 mg the numbers of patients with hypoglycemia documented by symptoms (such as dizziness, shakiness, sweating, and hunger) and a fingerstick blood glucose measurement ≤50 mg/dL were 5 (2.9%) for glipizide, 0 (0%) for metformin, 13 (7.6%) for METAGLIP 2.5 mg/250 mg, and 16 (9.3%) for METAGLIP 2.5 mg/500 mg. Among patients taking either METAGLIP 2.5 mg/250 mg or METAGLIP 2.5 mg/500 mg, 9 (2.6%) patients discontinued METAGLIP due to hypoglycemic symptoms and one required medical intervention due to hypoglycemia. In a controlled second-line therapy trial of METAGLIP 5 mg/500 mg, the numbers of patients with hypoglycemia documented by symptoms and a fingerstick blood glucose measurement ≤50 mg/dL were 0 (0%) for glipizide, 1 (1.3%) for metformin, and 11 (12.6%) for METAGLIP. One (1.1%) patient discontinued METAGLIP therapy due to hypoglycemic symptoms and none required medical intervention due to hypoglycemia. (See PRECAUTIONS.)
Gastrointestinal Reactions
Among the most common clinical adverse events in the initial therapy trial were diarrhea and nausea/vomiting; the incidences of these events were lower with both METAGLIP dosage strengths than with metformin therapy. There were 4 (1.2%) patients in the initial therapy trial who discontinued METAGLIP therapy due to GI adverse events. Gastrointestinal symptoms of diarrhea, nausea/vomiting, and abdominal pain were comparable among METAGLIP, glipizide and metformin in the second-line therapy trial. There were 4 (4.6%) patients in the second-line therapy trial who discontinued METAGLIP therapy due to GI adverse events.
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