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Clinical Trial Details

Trial ID: L7017
Source ID: NCT01702298
Associated Drug: Sitagliptin 100 Mg/Simvastatin 40 Mg Fdc
Title: A Study to Assess the Safety and Tolerability of Sitagliptin/Simvastatin Fixed-dose Combination (FDC) in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-312)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01702298/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin 100 mg/simvastatin 40 mg FDC|DRUG: Metformin
Outcome Measures: Primary: Change From Baseline in Fasting Plasma Glucose (FPG), Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time., Baseline and Week 6|Percentage of Participants Who Experienced at Least One Adverse Event, An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product., Up to 8 weeks (including 14 days after final dose of study drug)|Number of Participants Who Discontinued Study Drug Due to an Adverse Event, Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment., Up to 6 weeks | Secondary: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C), Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time., Baseline and Week 6|Change From Baseline in Total Cholesterol (TC), Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time., Baseline and Week 6|Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C), Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time., Baseline and Week 6|Change From Baseline in Triglycerides (TG), Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval)., Baseline and Week 6|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C), Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time., Baseline and Week 6
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 42
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-12-07
Completion Date: 2013-05-29
Results First Posted: 2014-05-30
Last Update Posted: 2018-08-24
Locations:
URL: https://clinicaltrials.gov/show/NCT01702298