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Clinical Trial Details

Trial ID: L5061
Source ID: NCT01703221
Associated Drug: Omarigliptin
Title: Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01703221/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Omarigliptin|DRUG: Sitagliptin|DRUG: Placebo to omarigliptin|DRUG: Placebo to sitagliptin
Outcome Measures: Primary: Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24, HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline)., Baseline and Week 24|Percentage of Participants Who Experienced at Least One Adverse Event During Phase A, An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to 24 weeks|Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only., Up to 52 weeks|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to 24 weeks|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study, An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only., Up to 52 weeks | Secondary: Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24, Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0., Baseline and Week 24|Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24, Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline)., Baseline and Week 24
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 414
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-10-24
Completion Date: 2014-04-25
Results First Posted: 2015-10-29
Last Update Posted: 2019-08-28
Locations:
URL: https://clinicaltrials.gov/show/NCT01703221