ng and 1000mg in the evening), and GLUMETZA 2000mg once daily were compared to immediate-release metformin 1500mg per day in divided doses (500mg in the morning and 1000mg in the evening). This trial enrolled patients (n= 338) who were newly diagnosed with diabetes, patients treated only with diet and exercise, patients treated with a single anti-diabetic medication (sulfonylureas, alpha-glucosidase inhibitors, thiazolidinediones, or meglinitides), and patients (n= 368) receiving metformin up to 1500mg/day plus a sulfonylurea at a dose equal to or less than one-half the maximum dose. Patients who were enrolled on monotherapy or combination anti-diabetic therapy underwent a 6-week washout. Patients randomized to GLUMETZA began titration from 1000mg/day up to their assigned treatment dose over 3weeks. Patients randomized to immediate-release metformin initiated 500mg twice daily for 1week followed by 500mg with breakfast and 1000mg with dinner for the second week. The 3-week treatment period was followed by an additional 21-week period at the randomized dose. For HbA1c and fasting plasma glucose, each of the GLUMETZA regimens was at least as effective as immediate-release metformin. Additionally, once daily dosing of GLUMETZA was as effective as twice daily dosing of the immediate release metformin formulation.
Table 4: Mean±SE Changes from Baseline to Final Visit in HbA1c, Fasting Plasma Glucose and Body Weight for the GLUMETZA and Metformin Immediate-Release Treatment Groups (First 24-Week Study) Parameter GLUMETZA Metformin immediate-release
1500mg in divided doses
(n= 174)
1500mg once daily
(n= 178) 1500mg in divided doses
(n= 182) 2000mg once daily
(n= 172)
HbA1c (%)
N 169 175 159 170
Baseline 8.2± 0.3 8.5± 0.2 8.3± 0.2 8.7± 0.3
Mean Change± SE at Final Visit -0.7± 0.1 -0.7± 0.1 -1.1± 0.1 -0.7± 0.1
Mean Difference± SE from Metformin IR 0± 0.1 0± 0.1 -0.4± 0.1 N/A
98.4% CI for Difference (-0.3, 0.3) (-0.3, 0.3) (-0.7, -0.1)
Fasting Plasma Glucose (mg/dL)
N 175 179 170 172
Baseline 190± 10 192.3± 10 184± 10 197± 11
Mean Change± SE at Final Visit -39± 4 -32± 4 -42± 5 -32± 5
Mean Difference± SE from Metformin IR -6± 4 0± 4 -10± 4 N/A
95% CI for Difference (-15, 2) (-8, 9) (-19, -1)
Body Weight (kg)
N 176 180 171 173
Baseline 88.2± 3.7 90.5± 3.7 87.7± 3.7 88.7± 3.9
Mean Change± SE at Final Visit -0.9± 0.4 -0.7± 0.4 -1.1± 0.4 -0.9± 0.4
Mean Difference± SE from Metformin IR -0.1± 0.4 0.2± 0.4 -0.3± 0.4 N/A
95% CI for Difference (-0.9, 0.7) (-0.6, 0.9) (-1.0, 0.5)
A Double-Blind, Randomized, Parallel-Group Study to Compare the Safety, Efficacy, and Tolerability of Metformin Extended Release (M-ER) Tablets in Combination with a Sulfonylurea (SU) and SU Alone in the Management of Patients with Type2 Diabetes Mellitus
In a double-blind, randomized, placebo-controlled (glyburide add-on) multicenter trial, patients with type2 diabetes mellitus who were newly diagnosed or treated with diet and exercise (n= 144), or who were receiving monotherapy with metformin, sulfonylureas, alp
