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Clinical Trial Details

Trial ID: L6852
Source ID: NCT02564211
Associated Drug: Ipragliflozin
Title: Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02564211/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Ipragliflozin|DRUG: Sitagliptin
Outcome Measures: Primary: Percentage of Participants Who Experienced at Least 1 Adverse Event (AE), An AE was any unfavorable or unintended sign, symptom, or disease, and a causal relationship to the relevant investigational product is not considered. An AE could therefore be any unfavorable and unintended sign, including results from laboratory assessments, physical examination, electrocardiograms, and vital sign assessments. The percentage of participants that had AE was recorded., Up to 54 weeks|Percentage of Participants Who Had Study Drug Discontinued Due to an AE, The percentage of participants who had study treatment stopped due to an AE regardless if they completed study., Up to 52 weeks | Secondary: Change From Baseline in HbA1c, Participants had HbA1c levels determined at baseline and at Week 52. HbA1c is reported as a percentage. A negative number reflects a decrease in percentage., Baseline and Week 52
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 77
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-10-26
Completion Date: 2017-03-07
Results First Posted: 2018-03-14
Last Update Posted: 2018-09-04
Locations:
URL: https://clinicaltrials.gov/show/NCT02564211