`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-044
`
`STATISTICAL REVIEW! S!
`
`
`
`Office of Biostatistics
`
`US. Department of Health and Human Services
`Food and Drug Administration
`Center for Drug Evaluan'on and Re5earch
`Office of Translational Science
`
`STATISTICAL REVIEW AND EVALUATION.
`
`CLINICAL STUDIES
`
`NDA/Serial Number:
`
`22_044
`
`Drug Name:
`
`Indication(s):
`
`Applicant:
`
`Date(s):
`
`(Sitagliptin Phosphate/Metformin Hydrochloride Fixed Dose
`Janumet
`Combination Tablet) 50/500 and 50/ 1000 mg/mg sitagliptin/metformin
`
`An adjunct to diet and'exercise to improve glycemic control in patients
`with type 2 diabetes mellitus who are not adequately controlled on
`metformin or sitagliptin alone or in patients already being treated with the
`combination of sitagliptin and metformin
`
`Merck & Co, Inc.
`
`Received 05/3 l /06; user fee (10 months) 03 /31 /07
`
`Review Priority:
`
`Standard
`
`Biometrics Division:
`
`Division of Biometrics 2
`
`Statistical Reviewer:
`
`Lee—Ping-Pian, Ph.D.
`
`\
`
`Concurring Reviewers:
`
`Todd Sahlroot, PhD. Biometrics Team Leader
`Thomas Permutt, Ph.D. Division Director
`
`'
`
`Medical Division:
`
`Division of Metabolism and Endocrinology Products (DNEEP)
`
`Clinical Team:
`
`Project Manager:
`
`Ilan Irony, M.D.
`Mary Parks, M.DI Division Director
`Lina Aljuburi, Pharm D.
`
`Keywords: New Drug Application (NDA) review, clinical studies
`
`
`
`Table ofContents
`
`1.1
`
`2.
`
`EXECUTIVE SUMMARY ............................................................................................................. 2
`
`1.1 CONCLUSIONS AND RECOMMENDATIONS ......................................................................................................... 2
`
`LABELING COMMENTS..-....................................................................................................... 2
`
`1. EXECUTIVE SUMMARY
`
`‘
`
`1.1 Conclusions and Recommendations
`
`The statistical review provides labeling comments only. The efficacy review for this NDA can be
`referenced to the statistical review for Januvia (NDA 21—995). Specifically, the original statistical review
`concerned protocol 020, a multinational, double-blind, randomized, parallel group Phase III study to
`evaluate the safety and efficacy of MK—043l 100 mg in patients with type 2 diabetes mellitus (T2DM) who
`have inadequate glycemic control on metformin therapy.
`
`2. LABELING COMMENTS
`
`1. The second study (protocol 015) should not be included in the clinical studies section. The
`study was a cross-over PD assessment of 24—hour plasma glucose values in 28 patients after
`4 weeks of treatment. It was not reviewed as a well controlled clinical study.
`
`2.
`
`I"
`
`Appears This Way
`On Original
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`/s/
`‘
`'
`
`Lee—Ping Pian
`3/2/2007 04:04:01 PM
`BIOMETRICS
`
`' Todd Sahlroot
`3/5/2007 08:08:40 AM
`BIOMETRICS
`
`Appears This Way
`On Original
`
`
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