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Clinical Trial Details

Trial ID: L2129
Source ID: NCT01131182
Associated Drug: Sitagliptin Phosphate
Title: Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01131182/results
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Sitagliptin phosphate|DRUG: Comparator: Sulfonylurea|DRUG: Metformin
Outcome Measures: Primary: Proportion of Participants With at Least One Symptomatic Hypoglycemic Event, Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change., 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10) | Secondary: Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event, Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change., 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 1147
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-06-13
Completion Date: 2010-11-04
Results First Posted: 2012-01-20
Last Update Posted: 2022-09-21
Locations:
URL: https://clinicaltrials.gov/show/NCT01131182