Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5553
Source ID: NCT00094770
Associated Drug: Sitagliptin (Mk0431)
Title: An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00094770/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: sitagliptin (MK0431)|DRUG: Comparator: glipizide
Outcome Measures: Primary: Change From Baseline in HbA1c at Week 52, HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent., Baseline and Week 52 | Secondary: Change From Baseline in HbA1c at Week 104, HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent., Baseline and Week 104|Change From Baseline in Body Weight at Week 52, Change from baseline at Week 52 is defined as Week 52 minus Week 0., Baseline and Week 52|Change From Baseline in Body Weight at Week 104, Change from baseline at Week 104 is defined as Week 104 minus Week 0., Baseline and Week 104|Hypoglycemic Events at Week 52, Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia., Baseline to Week 52|Hypoglycemic Events at Week 104, Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia., Baseline to Week 104|Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104, An adverse experience (AE) 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., Baseline to Week 104|Number of Participants With Serious CAEs at Week 104, Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose., Baseline to Week 104|Number of Participants With Drug-related CAEs at Week 104, Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs., Baseline to Week 104|Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104, A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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., Baseline to Week 104|Number of Participants With Serious LAEs at Week 104, Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose., Baseline to Week 104|Number of Participants With Drug-related LAEs at Week 104, Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs., Baseline to Week 104
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1172
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2004-09
Completion Date: 2007-05
Results First Posted: 2009-12-22
Last Update Posted: 2016-08-26
Locations:
URL: https://clinicaltrials.gov/show/NCT00094770