CLINICAL STUDIES
GLUMETZA has been studied as monotherapy and in combination with a sulfonylurea and insulin.

In a multicenter, randomized, double-blind, active-controlled, dose-ranging, parallel group study GLUMETZA 1500mg once a day, GLUMETZA 1500 per day in divided doses (500mg in the morning and 1000mg in the evening), and GLUMETZA 2000mg once a day were compared to immediate release metformin 1500mg per day in divided doses (500mg in the morning and 1000mg in the evening). (SeeTable3) Newly diagnosed patients, diet-and-exercise-treated (diet/exercise) patients, patients who received combination therapy consisting of metformin up to 1500mg/day plus a sulfonylurea at a dose equal to or less than one-half the maximum dose allowed (following a 6-week washout), or patients on monotherapy with an antihyperglycemic agent (following a 6-week washout) were randomized to treatment and began titration from 1000mg/day up to their assigned treatment dose over 3weeks. Metformin IR treatment was initiated as 500mg BID 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. Each of the GLUMETZA regimens were at least as effective as immediate release metformin in all measures of glycemic control. Additionally, once daily dosing was as effective as the commonly prescribed twice daily dosing of the immediate release metformin formulation.

Table 3: Mean±SE Changes from Baseline to Final Visit in HbA1c, Fasting Plasma Glucose and Body Weight for the GLUMETZA and Metformin IR Treatment Groups (First 24-Week Study)  Parameter  GLUMETZA  Metformin IR
1500mg AM/PM
(n =174) 
1500mg QD
(n =178)  1500mg AM/PM
(n =182)  2000mg QD
(n =172) 
HbA1c (%)
n  169  175  159  170 
Baseline  8.22 ±0.25  8.50 ±0.24  8.26 ±0.24  8.70 ±0.25 
Mean Change ±SE at Final Visit  -0.73 ±0.12  -0.74 ±0.12  -1.06 ±0.12  -0.70 ±0.12 
Mean Difference ±SE from Metformin IR  -0.03 ±0.12  -0.04 ±0.12  -0.36 ±0.12  N/A 
98.4% CI for Difference  (-0.32, 0.26)  (-0.33, 0.25)  (-0.65, -0.06) 
 
Fasting Plasma Glucose (mg/dL)
n  175  179  170  172 
Baseline  190.0 ±9.9  192.5 ±9.9  183.9 ±9.9  196.5 ±11.2 
Mean Change ±SE at Final Visit  -38.5 ±4.4  -31.8 ±4.4  -42.0 ±4.5  -32.1 ±4.5 
Mean Difference ±SE from Metformin IR  -6.4 ±4.4  0.2 ±4.3  -9.9 ±4.4  N/A 
95% CI for Difference  (-15.0, 2.1)  (-8.3, 8.7)  (-18.5, -1.3) 
 
Body Weight (kg)
n  176  180  171  173 
Baseline  88.17 ±3.66  90.50 ±3.66  87.73 ±3.66  88.72 ±3.87 
Mean Change ±SE at Final Visit  -0.93 ±0.40  -0.68 ±0.40  -1.10 ±0.40  -0.85 ±0.41 
Mean Difference ±