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Clinical Trial Details

Trial ID: L3000
Source ID: NCT00481663
Associated Drug: Sitagliptin
Title: A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type II Diabetes Mellitus
Interventions: DRUG: Sitagliptin|DRUG: Placebo to sitagliptin|DRUG: Metformin|DRUG: Rescue
Outcome Measures: Primary: Change from Baseline in HbA1C at Week 12, Baseline and Week 12|Number of Participants Who Experienced One or More Adverse Events (AE) up to Week 14, Up to Week 14|Number of Participants Who Experienced One or More AE up to Week 54, Up to Week 54|Number of Participants Who Experienced One or More AE up to Week 108, Up to Week 108|Number of Participants Who Experienced One or More AE up to Week 160, Up to Week 160|Number of participants Who Discontinued Study Treatment Due to An AE up to Week 12, Up to Week 12|Number of participants Who Discontinued Study Treatment Due to An AE up to Week 52, Up to Week 52|Number of participants Who Discontinued Study Treatment Due to An AE up to Week 106, Up to Week 106|Number of participants Who Discontinued Study Treatment Due to An AE up to Week 158, Up to Week 158 | Secondary: Change from Baseline in HbA1C at Week 52, Baseline and Week 52|Change from Baseline in HbA1C at Week 106, Baseline and Week 106|Change from Baseline in HbA1C at Week 158, Baseline and Week 158|Change from Baseline in Fasting Plasma Glucose (FPG) at Week 12, Baseline and Week 12|Change from Baseline in FPG at Week 52, Baseline and Week 52|Change from Baseline in FPG at Week 106, Baseline and Week 106|Change from Baseline in FPG at Week 158, Baseline and Week 158|Change from Baseline in Body Weight at Week 12, Baseline and Week 12|Change from Baseline in Body Weight at Week 52, Baseline and Week 52|Change from Baseline in Body Weight at Week 106, Baseline and Week 106|Change from Baseline in Body Weight at Week 158, Baseline and Week 158|Change From Baseline in Serum Fructosamine at Week 12, Baseline and Week 12|Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 12, Baseline and Week 12|Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 52, Baseline and Week 52
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 555
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2003-08-19
Completion Date: 2006-05-14
Results First Posted:
Last Update Posted: 2017-04-04
Locations:
URL: https://clinicaltrials.gov/show/NCT00481663