t improvements in A1C, FPG, and 2-hour PPG compared to placebo, to metformin alone, and to JANUVIA alone (Table 6, Figure 1). Mean reductions from baseline in A1C were generally greater for patients with higher baseline A1C values. For patients not on an antihyperglycemic agent at study entry, mean reductions from baseline in A1C were: JANUVIA 100 mg once daily, -1.1%; metformin 500 mg bid, -1.1%; metformin 1000 mg bid, -1.2%; sitagliptin 50 mg bid with metformin 500 mg bid, -1.6%; sitagliptin 50 mg bid with metformin 1000 mg bid, -1.9%; and for patients receiving placebo, -0.2%. Lipid effects were generally neutral. The decrease in body weight in the groups given sitagliptin in combination with metformin was similar to that in the groups given metformin alone or placebo.
Table 6: Glycemic Parameters at Final Visit (24-Week Study) for Sitagliptin and Metformin, Alone and in Combination as Initial Therapy* Placebo
Sitagliptin
(JANUVIA)
100 mg QD
Metformin
500 mg bid Metformin
1000 mg bid Sitagliptin
50 mg bid +
Metformin
500 mg bid Sitagliptin
50 mg bid +
Metformin
1000 mg bid
* Intent-to-treat population using last observation on study prior to glyburide (glibenclamide) rescue therapy. † Least squares means adjusted for prior antihyperglycemic therapy status and baseline value. ‡ p<0.001 compared to placebo.
A1C (%) N = 165 N = 175 N = 178 N = 177 N = 183 N = 178
Baseline (mean) 8.7 8.9 8.9 8.7 8.8 8.8
Change from baseline (adjusted mean†) 0.2 -0.7 -0.8 -1.1 -1.4 -1.9
Difference from placebo (adjusted mean†) (95% CI) -0.8‡
(-1.1, -0.6) -1.0‡
(-1.2, -0.8) -1.3‡
(-1.5, -1.1) -1.6‡
(-1.8, -1.3) -2.1‡
(-2.3, -1.8)
Patients (%) achieving A1C <7% 15 (9%) 35 (20%) 41 (23%) 68 (38%) 79 (43%) 118 (66%)
% Patients receiving rescue medication 32 21 17 12 8 2
FPG (mg/dL) N = 169 N = 178 N = 179 N = 179 N = 183 N = 180
Baseline (mean) 196 201 205 197 204 197
Change from baseline (adjusted mean†) 6 -17 -27 -29 -47 -64
Difference from placebo (adjusted mean†) (95% CI) -23‡
(-33, -14) -33‡
(-43, -24) -35‡
(-45, -26) -53‡
(-62, -43) -70‡
(-79, -60)
2-hour PPG (mg/dL) N = 129 N = 136 N = 141 N = 138 N = 147 N = 152
Baseline (mean) 277 285 293 283 292 287
Change from baseline (adjusted mean†) 0 -52 -53 -78 -93 -117
Difference from placebo (adjusted mean†) (95% CI) -52‡
(-67, -37) -54‡
(-69, -39) -78‡
(-93, -63) -93‡
(-107, -78) -117‡
(-131, -102)
Figure 1: Mean Change from Baseline for A1C (%) over 24 Weeks with Sitagliptin and Metformin, Alone and in Combination as Initial Therapy in Patients with Type 2 Diabetes* * All Patients Treated Population: least squares means adjusted for prior antihyperglycemic therapy and baseline value.
Initial combination therapy or maintenance of combination therapy may not be appropriate for all patients. These management options are left to the discretion of the health care provider.
Active-Controlled Study vs Glipizide in Combination with Metformin
The efficacy of JANUVIA was eva luated in a 52-week, double-blind, glipizide-controlled noninferiority trial in patients with type 2 diabetes. Patients not on treatm |
