Glimepiride (Page 5 of 6)

14 CLINICAL STUDIES

14.1 Monotherapy

A total of 304 patients with type 2 diabetes already treated with sulfonylurea therapy participated in a 14-week, multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of glimepiride monotherapy. Patients discontinued their sulfonylurea therapy then entered a 3-week placebo washout period followed by randomization into 1 of 4 treatment groups: placebo (n=74), glimepiride 1 mg (n=78), glimepiride 4 mg (n=76), and glimepiride 8 mg (n=76). All patients randomized to glimepiride started 1 mg daily. Patients randomized to glimepiride 4 mg or 8 mg had blinded, forced titration of the glimepiride dose at weekly intervals, first to 4 mg and then to 8 mg, as long as the dose was tolerated, until the randomized dose was reached. Patients randomized to the 4 mg dose reached the assigned dose at Week 2. Patients randomized to the 8 mg dose reached the assigned dose at Week 3. Once the randomized dose level was reached, patients were to be maintained at that dose until Week 14. Approximately 66% of the placebo-treated patients completed the trial compared to 81% of patients treated with glimepiride 1 mg and 92% of patients treated with glimepiride 4 mg or 8 mg. Compared to placebo, treatment with glimepiride 1 mg, 4 mg, and 8 mg daily provided statistically significant improvements in HbA1C compared to placebo (Table 3).

Table 3: 14-Week Monotherapy Trial Comparing Glimepiride to Placebo in Patients Previously Treated With Sulfonylurea Therapya
Placebo(N=74) Glimepiride
1 mg (N=78) 4 mg (N=76) 8 mg (N=76)
a Intent-to-treat population using last observation on studyb Least squares mean adjusted for baseline value* p <0.001
HbA1C (%)
n=59 n=65 n=65 n=68
Baseline (mean) 8 7.9 7.9 8
Change from Baseline (adjusted meanb) 1.5 0.3 -0.3 -0.4
Difference from Placebo (adjusted meanb) 95% confidence interval -1.2*(-1.5, -0.8) -1.8*(-2.1, -1.4) -1.8*(-2.2, -1.5)
Mean Baseline Weight (kg)
n=67 n=76 n=75 n=73
Baseline (mean) 85.7 84.3 86.1 85.5
Change from Baseline (adjusted meanb) -2.3 -0.2 0.5 1
Difference from Placebo (adjusted meanb) 95% confidence interval 2*(1.4, 2.7) 2.8*(2.1, 3.5) 3.2*(2.5, 4)

A total of 249 patients who were treatment-naive or who had received limited treatment with antidiabetic therapy in the past were randomized to receive 22 weeks of treatment with either glimepiride (n=123) or placebo (n=126) in a multicenter, randomized, double-blind, placebo-controlled, dose-titration trial. The starting dose of glimepiride was 1 mg daily and was titrated upward or downward at 2-week intervals to a goal FPG of 90 to 150 mg/dL. Blood glucose levels for both FPG and PPG were analyzed in the laboratory. Following 10 weeks of dose adjustment, patients were maintained at their optimal dose (1, 2, 3, 4, 6, or 8 mg) for the remaining 12 weeks of the trial. Treatment with glimepiride provided statistically significant improvements in HbA1C and FPG compared to placebo (Table 4).

Table 4: 22-Week Monotherapy Trial Comparing Glimepiride to Placebo in Patients Who Were Treatment-Naive or Who Had No Recent Treatment with Antidiabetic Therapya
Placebo (N=126) Glimepiride(N=123)
a Intent-to-treat population using last observation on study b Least squares mean adjusted for baseline value * p <0.0001
HbA1C (%) n=97 n=106
Baseline (mean) 9.1 9.3
Change from Baseline (adjusted meanb) -1.1* -2.2*
Difference from Placebo (adjusted meanb) 95% confidence interval -1.1*(-1.5, -0.8)
Body Weight (kg)
n=122 n=119
Baseline (mean) 86.5 87.1
Change from Baseline (adjusted meanb) -0.9 1.8
Difference from Placebo (adjusted meanb) 95% confidence interval 2.7 (1.9, 3.6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Glimepiride tablets, USP are available in the following strengths and package sizes:

Glimepiride Tablets USP, 1 mg are pink colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “X” and “76” on either side of the bisect on one face and plain on the other face.
Bottles of 100 NDC 65862-579-01
Bottles of 500 NDC 65862-579-05
Bottles of 1,000 NDC 65862-579-99

Glimepiride Tablets USP, 2 mg are light green to green colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “Y” and “32” on either side of the bisect on one face and plain on the other face.
Bottles of 100 NDC 65862-580-01
Bottles of 500 NDC 65862-580-05
Bottles of 1,000 NDC 65862-580-99

Glimepiride Tablets USP, 4 mg are light blue to blue colored, flat-faced, oblong uncoated tablets with notched sides at double bisect, debossed with “Y” and “34” on either side of the bisect on one face and plain on the other face.
Bottles of 100 NDC 65862-581-01
Bottles of 250 NDC 65862-581-25
Bottles of 500 NDC 65862-581-05
Bottles of 1,000 NDC 65862-581-99
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in well-closed containers with safety closures.

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