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Clinical Trial Details

Trial ID: L6636
Source ID: NCT01034111
Associated Drug: Sitagliptin Phosphate
Title: A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01034111/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Sitagliptin phosphate|DRUG: Metformin
Outcome Measures: Primary: Safety and Tolerability of Sitagliptin After 4 Weeks of Treatment, Safety \& tolerability were measured in terms of the # of participants with \>=1 adverse event (AE), \>=1 drug-related AE, \>=1 serious AE (SAE), or discontinued treatment due to an AE. SAEs included events occurring after initiation of glycemic rescue therapy. AE is defined as any unfavorable/unintended change in structure, function, or chemistry of the body temporally associated with the use of SPONSOR's product. SAE is defined as any AE that results in death, is life-threatening, an overdose, causes or prolongs in-patient hospitalization, or considered medically significant by the investigator., 4 weeks | Secondary: Change From Baseline in Fasting Plasma Glucose at Week 4, Calculated as the mean change from baseline in fasting plasma glucose at Week 4., Baseline and Week 4
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-03-01
Completion Date: 2010-10-04
Results First Posted: 2011-11-06
Last Update Posted: 2017-05-30
Locations:
URL: https://clinicaltrials.gov/show/NCT01034111