`
`NCT01196546 on 2010_09_07: ClinicalTrials.gov Archive
`
`← History of this study
`↑ Current version of this study
`View of NCT01196546 on 2010_09_07
`ClinicalTrials Identifier: NCT01196546
`Updated:
`2010_09_07
`
`Descriptive Information
`Brief title
`
`Official title
`
`Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin
`in Patients in Type 2 Diabetes Mellitus (T2DM)
`Multi-center, Open-label, 24-week Study to Demonstrate the Efficacy
`and Safety of Combination Therapy of Vildagliptin/Metformin 50/500
`or 50/1000 mg Twice Daily in Patients With T2DM Inadequately
`Controlled With Metformin
`
`Brief summary
`This study will assess the efficacy and safety of combination therapy of
`vildagliptin/metformin in patients with T2DM inadequately controlled with metformin
`1,000 mg/day.
`Detailed description
`
`Phase
`Study type
`Study design
`Study design
`Study design
`Primary outcome
`
`Secondary outcome
`
`Secondary outcome
`
`Enrollment
`Condition
`Arm/Group
`
`Intervention
`
`Phase 4
`Interventional
`Treatment
`Open Label
`Single Group Assignment
`Measure: HbA1c reduction
`Time Frame: 24 weeks after treatment
`Safety Issue? No
`Measure: Proportion of patients who achieve target of HbA1c<6.5%
`at the end of study
`Time Frame: 24 weeks after treatment
`Safety Issue? No
`Measure: To evaluate the effect of combination therapy of vildagliptin
`(50 mg) plus metformin (500 or 1000 mg) twice daily on FPG and
`BMI, safety and tolerability profiles
`Time Frame: 24 weeks after treatment
`Safety Issue? Yes
`200 (Anticipated)
`Type 2 Diabetes Mellitus
`Arm Label: Vildagliptin/metformin Experimental
`
`Drug: vildagliptin/metformin Arm Label: Vildagliptin/metformin
`
`https://clinicaltrials.gov/archive/NCT01196546/2010_09_07
`
`1/2
`
`Boehringer Ex. 2015
`Mylan v. Boehringer Ingelheim
`IPR2016-01566
`Page 1
`
`
`
`NCT01196546 on 2010_09_07: ClinicalTrials.gov Archive
`
`11/9/2016
`Recruitment Information
`Status
`Start date
`Primary completion
`date
`Criteria
`Inclusion Criteria:
` - Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000
`mg daily for at least 3 months
` - The patient is required to have HbA1c 6.5-11.0%
` - BMI in the range of 22-48 kg/m2
`
`Recruiting
`2010-03
`2011-06 (Anticipated)
`
`Exclusion Criteria:
` - Severe or uncontrolled Type 2 diabetes mellitus (HbA1c> 11.0%)
` - Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state
`(coma) within the past 6 months
` - Congestive heart failure requiring pharmacologic treatment
` - Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina
`(3) coronary artery bypass surgery or percutaneous coronary intervention
` - Liver disease such as cirrhosis or chronic active hepatitis
`Gender
`Both
`Minimum age
`18 Years
`Maximum age
`78 Years
`Healthy volunteers
`Yes
`
`Administrative Data
`Organization name
`Novartis
`Organization study ID CLMF237ATH01
`Sponsor
`Novartis
`Health Authority
`Thailand: Ethical Committee
`
`
`
`https://clinicaltrials.gov/archive/NCT01196546/2010_09_07
`
`2/2
`
`Boehringer Ex. 2015
`Mylan v. Boehringer Ingelheim
`IPR2016-01566
`Page 2
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