After 52 weeks, sitagliptin and glipizide had similar mean reductions from baseline in A1C in the intent-to-treat analysis (Table 9). These results were consistent with the per protocol analysis (Figure 2). A conclusion in favor of the non-inferiority of sitagliptin to glipizide may be limited to patients with baseline A1C comparable to those included in the study (over 70% of patients had baseline A1C <8% and over 90% had A1C <9%).

Table 9: Glycemic Parameters in a 52-Week Study Comparing Sitagliptin to Glipizide as Add-On Therapy in Patients Inadequately Controlled on Metformin (Intent-to-Treat Population)*  Sitagliptin 100 mg
+ Metformin Glipizide
+ Metformin
*
The intent-to-treat analysis used the patients' last observation in the study prior to discontinuation.
†
Least squares means adjusted for prior antihyperglycemic therapy status and baseline A1C value.
A1C (%) N = 576 N = 559
Baseline (mean) 7.7 7.6
Change from baseline (adjusted mean†) -0.5 -0.6
FPG (mg/dL)  N = 583 N = 568
Baseline (mean)  166 164
Change from baseline (adjusted mean†) -8 -8

Figure 2: Mean Change from Baseline for A1C (%) Over 52 Weeks in a Study Comparing Sitagliptin to Glipizide as Add-On Therapy in Patients Inadequately Controlled on Metformin (Per Protocol Population)†

The incidence of hypoglycemia in the sitagliptin group (4.9%) was significantly (p<0.001) lower than that in the glipizide group (32.0%). Patients treated with sitagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glipizide (-1.5kg vs. +1.1kg).

16 HOW SUPPLIED/STORAGE AND HANDLING
No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with “575” debossed on one side. They are supplied as follows:

NDC0006-0575-61 unit-of-use bottles of 60

NDC0006-0575-62 unit-of-use bottles of 180

NDC0006-0575-52 unit dose blister packages of 50

NDC0006-0575-82 bulk bottles of 1000.

No.6749— Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with “577” debossed on one side. They are supplied as follows:

NDC0006-0577-61 unit-of-use bottles of 60

NDC0006-0577-62 unit-of-use bottles of 180

NDC0006-0577-52 unit dose blister packages of 50

NDC0006-0577-82 bulk bottles of 1000.

Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F), [See USP Controlled Room Temperature].

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

9984503

US Patent No.: 6,699,871

1,2 Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

3 GLUCOPHAGE® is a registered trademark of Merck Sante S.A.S, an associate of Merck KGaA of Darmstadt, Germany.
Licensed to Bristol-Myers Squibb Company.

Copyright © 2007, 2008, 2009, 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved

17 PATIENT COUNSELING INFORMATION
See FDA-approved Medication Guide.

17.1 Instructions
Patients should be informed of the potential risks and benefits of JANUMET and of alternativ