tudies.
†
The result of subtracting the placebo group average.
‡
t.i.d. = 3 times daily
§
p≤ 0.05
¶
Although results for the 200 mg 3 times daily are presented for completeness, the maximum recommended dosage of GLYSET is 100 mg 3 times daily.
1
(U.S.) Placebo +0.71 --- +24 ---
GLYSET 50 mg t.i.d.‡ +0.13 -0.58§ -39 -63§
2
(U.S.) Placebo +0.47 --- +15 ---
GLYSET 50 mg t.i.d. -0.22 -0.69§ -52 -67§
GLYSET 100 mg t.i.d. -0.28 -0.75§ -59 -74§
3
(non-U.S.) Placebo +0.18 --- +2 ---
GLYSET 25 mg t.i.d. -0.08 -0.26 -33 -35§
GLYSET 50 mg t.i.d. -0.22 -0.40 -45 -47§
GLYSET 100 mg t.i.d. -0.63 -0.81§ -62 -64§
GLYSET 200 mg t.i.d. ¶ -0.84 -1.02§ -85 -87§
4
(non-U.S.) Placebo +0.01 --- +8 ---
GLYSET 50 mg t.i.d. -0.35 -0.36§ -20 -28§
GLYSET 100 mg t.i.d. -0.57 -0.58§ -25 -33§
5
(non-U.S.) Placebo +0.32 --- +17 ---
GLYSET 100 mg t.i.d. -0.43 -0.75§ -38 -55§
Clinical Experience in NIDDM Patients Receiving Sulfonylureas
GLYSET was studied as adjunctive therapy to a background of maximal or near-maximal sulfonylurea (SFU) treatment in three large, double-blind, randomized studies (two U.S. and one non-U.S.) in which 471 patients treated with GLYSET were eva luated for efficacy (see Table 2).
Study 6 included patients under treatment with maximal doses of SFU at entry. At the end of this 14-week study, the mean treatment effects on glycosylated hemoglobin (HbA1c) were -0.82% and -0.74% for patients receiving GLYSET 50 mg 3 times daily plus SFU, and GLYSET 100 mg 3 times daily plus SFU, respectively.
Study 7 was a one-year study in which GLYSET at 25, 50 or 100 mg 3 times daily was added to a maximal dose of glyburide (10 mg twice daily). At the end of this study, the mean treatment effects on HbA1c of GLYSET when added to maximum glyburide therapy were -0.30%, -0.62%, and -0.73% with the 25, 50 and 100 mg 3 times daily dosages of GLYSET, respectively.
In Study 8, the addition of GLYSET 100 mg 3 times daily to a background of treatment with glyburide produced an additional mean treatment effect on HbA1c of -0.66%.
Table 2 Results of Combination Therapy with GLYSET Plus Sulfonylurea (SFU) HbA1c
(%) 1-hour
Postprandial Glucose
(mg/dL)
Study Treatment Mean Change from Baseline* Treatment Effect† Mean Change from Baseline Treatment Effect†
*
Mean baseline ranged from 8.56 to 9.16% in these studies.
†
The result of subtracting the placebo group average.
‡
t.i.d. = 3 times daily
§
p≤ 0.05
6
(U.S.) Placebo + SFU +0.33 --- -1 ---
GLYSET 50 mg t.i.d.‡ + SFU -0.49 -0.82§ -69 -68§
GLYSET 100 mg t.i.d. + SFU -0.41 -0.74§ -73 -72§
7
(U.S.) Placebo + SFU +1.01 --- 48 ---
GLYSET 25 mg t.i.d. + SFU +0.71 -0.30 -2 -50§
GLYSET 50 mg t.i.d. + SFU +0.39 -0.62§ -13 -61§
GLYSET 100 mg t.i.d. + SFU +0.28 -0.73§ -33 -81§
8
(non-U.S.) Placebo + SFU +0.16 --- +10 ---
GLYSET 100 mg t.i.d. + SFU -0.50 -0.66§ -36 -46§
Dose-Response
Results from controlled, fixed-dose studies of GLYSET as monotherapy or as combination treatment with a sulfonylurea were combined to derive a pooled estimate of the difference from placebo in the mean change from baseline in glycosylated hemoglobin (HbA1c) and postprandial pl
