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Clinical Trial Details

Trial ID: L7238
Source ID: NCT01477853
Associated Drug: Sitagliptin
Title: A Study of the Co-administration of Sitagliptin and Atorvastatin in Inadequately Controlled Type 2 Diabetes Mellitus (MK-0431E-211)
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01477853/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin|DRUG: Atorvastatin|OTHER: Placebo to sitagliptin|OTHER: Placebo to atorvastatin|DRUG: Metformin (open-label)|DRUG: Glimepiride (open-label)|DRUG: Glimepiride (double-blind)|DRUG: Placebo to glimepiride
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1C (A1C) at Week 16, A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent., Baseline and Week 16|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Number 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 investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy., Up to 56 weeks (including 2-week follow-up)|Number of Participants Who Discontinued Study Drug Due to an 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 investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy., Up to 54 weeks | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16, Change from baseline reflects the Week 16 value minus the Week 0 value., Baseline and Week 16|Percent Change From Baseline in Total Cholesterol at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in Triglycerides at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16, Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%., Baseline and Week 16
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 166
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-10-24
Completion Date: 2012-12-04
Results First Posted: 2016-10-05
Last Update Posted: 2018-07-26
Locations:
URL: https://clinicaltrials.gov/show/NCT01477853