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Clinical Trial Details

Trial ID: L2406
Source ID: NCT02291874
Associated Drug: Ipragliflozin
Title: Post-Marketing Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Ipragliflozin in Combination With GLP-1 Receptor Agonists in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Ipragliflozin
Outcome Measures: Primary: HbA1c, at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week|Fasting plasma glucose, at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week | Secondary: Fasting serum insulin, at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week|Serum glucagon, at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week|Serum glycoalbumin, at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week|Serum leptin, at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week|Serum adiponectin, at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week|Body weight, 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week|Waist circumference, at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week|Self-measured blood glucose, Subjects measure blood glucose 7 times a day on any 3 days in a week before each scheduled visit and record the results in the patient diary, at 0, 20, 52-week|Adverse events (AEs), vital signs, and laboratory tests, All treatment period
Sponsor/Collaborators: Sponsor: Astellas Pharma Inc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-10-08
Completion Date: 2016-07-07
Results First Posted:
Last Update Posted: 2024-11-08
Locations: Chubu, Japan|Chugoku, Japan|Hokkaido, Japan|Kansai, Japan|Kanto, Japan|Kyushu, Japan
URL: https://clinicaltrials.gov/show/NCT02291874