Glucovance

[Glyburide/Metformin]

As second-line therapy in patients inadequately controlled on sulfonylurea alone, approximately 6.8% of all patients treated with GLUCOVANCE experienced hypoglycemic symp-toms. When rosiglitazone was added to GLUCOVANCE therapy, 22% of patients reported one or more fingerstick glucose measurements 50 mg/ dL compared to 3.3% of placebo-treated patients. All hypoglycemic events were managed by the patients and only one patient discontinued for hypo-glycemia. (See PRECAUTIONS: General; Addition of Thiazolidinediones to GLUCOVANCE Therapy.)

Gastrointestinal Reactions

The incidence of GI side effects (diarrhea, nausea/ vomiting, and abdominal pain) in the initial therapy trial are summarized in Table 6. Across all GLUCOVANCE trials, GI symptoms were the most common adverse events with GLUCOVANCE and were more frequent at higher dose levels. In controlled trials, <2% of patients discontinued GLUCOVANCE therapy due to GI adverse events.

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Table 5. Most Common Clinical Adverse Events (> 5 Percent) in Double-Blind Clinical Studies of GLUCOVANCE Used as Initial or Second-Line Therapy
Number (%) of Patients

Placebo Glyburide Metformin GLUCOVANCE Adverse Event N= 161 N= 324 N= 312 N= 642

Upper respiratory infection 22 (13.7) 57 (17.6) 51 (16.3) 111 (17.3)
Diarrhea 9 (5.6) 20 (6.2) 64 (20.5) 109 (17.0)
Headache 17 (10.6) 37 (11.4) 29 (9.3) 57 (8.9)
Nausea/ vomiting 10 (6.2) 17 (5.2) 38 (12.2) 49 (7.6)
Abdominal pain 6 (3.7) 10 (3.1) 25 (8.0) 44 (6.9)
Dizziness 7 (4.3) 18 (5.6) 12 (3.8) 35 (5.5)

Table 6. Treatment Emergent Symptoms of Hypoglycemia or Gastrointestinal Adverse Events in a Placebo-and Active-Controlled Trial of GLUCOVANCE as Initial Therapy
GLUCOVANCE GLUCOVANCE Glyburide Metformin 1.25 mg/ 250 mg 2.5 mg/ 500 mg
Placebo tablets tablets tablets tablets Variable N= 161 N= 160 N= 159 N= 158 N= 162

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