ADVERSE REACTIONS
Glipizide/Metformin HCl tablets
In a double-blind 24-week clinical trial involving glipizide/metformin HCl tablet as initial therapy, a total of 172 patients received glipizide/metformin HCl tablet 2.5 mg/250 mg, 173 received glipizide/metformin HCl tablet 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 | Glipizide/Metformin HCl
Tablets
2.5 mg/250 mg tablets
N=172 | Glipizide/Metformin HCl
Tablets
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 glipizide/metformin HCl tablet as second-line therapy, a total of 87 patients received glipizide/metformin HCl tablet, 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 | Glipizide/Metformin HCl
Tablets
5 mg/500 mg tabletsa
N=87 |
|---|
a The dose of glipizide was fixed at 30 mg daily; doses of metformin and Glipizide/Metformin HCl tablets 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 glipizide/metformin HCl tablet 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 glipizide/metformin HCl tablet 2.5 mg/250 mg, and 16 (9.3%) for glipizide/metformin HCl tablet 2.5 mg/500 mg. Among patients taking either glipizide/metformin HCl tablet 2.5 mg/250 mg or glipizide/metformin HCl tablet 2.5 mg/500 mg, nine (2.6%) patients discontinued glipizide/metformin HCl tablet due to hypoglycemic symptoms and one required medical intervention due to hypoglycemia. In a controlled second-line therapy trial of glipizide/metformin HCl tablet 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 glipizide/metformin HCl tablet. One (1.1%) patient discontinued glipizide/metformin HCl tablet therapy due to hypoglycemic symptoms and none required medical intervention due to hypoglycemia. (See PRECAUTIONS.)
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