`
`NCT00103857 on 2006_02_22: ClinicalTrials.gov Archive
`
`← History of this study
`↑ Current version of this study
`View of NCT00103857 on 2006_02_22
`ClinicalTrials Identifier: NCT00103857
`Updated:
`2006_02_22
`
`Descriptive Information
`Brief title
`
`Official title
`
`An Investigational Drug Study in Patients With Type 2 Diabetes
`Mellitus
`A Multicenter, Randomized, Double-Blind Factorial Study of the Co-
`Administration of MK0431 and Metformin in Patients With Type 2
`Diabetes Mellitus Who Have Inadequate Glycemic Control
`
`Brief summary
`The purpose of this study is to determine the safety and effectiveness of an
`investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of
`diabetes).
`Detailed description
`Duration of Treatment: 5.5 months
`Phase 3
`Interventional
`Treatment
`Measure: HbA1c
`Measure: FPG; fructosamine; glucose, insulin, and C-peptide profiles
`measured by MTT; proporation of patients meetings pre-specified
`rescue criteria; lipid panel; body weight; waist circumference; and
`appetite assessment.
`Type 2 Diabetes Mellitus
`Drug: MK0431, sitagliptin phosphate
`Drug: Comparator: metformin 500 mg bid
`Drug: Comparator: metformin 1000 mg bid
`Drug: Comparator: placebo
`
`Phase
`Study type
`Study design
`Primary outcome
`Secondary outcome
`
`Condition
`Intervention
`Intervention
`Intervention
`Intervention
`
`Recruitment Information
`Status
`Criteria
`Inclusion Criteria:
` - Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type
`of diabetes).
`
`No longer recruiting
`
`Exclusion Criteria:
` - Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes).
`Gender
`Both
`
`https://clinicaltrials.gov/archive/NCT00103857/2006_02_22
`
`1/2
`
`Boehringer Ex. 2014
`Mylan v. Boehringer Ingelheim
`IPR2016-01563
`Page 1
`
`
`
`11/9/2016
`
`Minimum age
`Maximum age
`Healthy volunteers
`Expected enrollment
`
`NCT00103857 on 2006_02_22: ClinicalTrials.gov Archive
`18 Years
`78 Years
`No
`1050
`
`Administrative Data
`Organization name
`Merck
`Organization study ID 2005_003
`Sponsor
`Merck
`Health Authority
`United States: Food and Drug Administration
`
`
`
`https://clinicaltrials.gov/archive/NCT00103857/2006_02_22
`
`2/2
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`Boehringer Ex. 2014
`Mylan v. Boehringer Ingelheim
`IPR2016-01563
`Page 2
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