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Clinical Trial Details

Trial ID: L2970
Source ID: NCT02201004
Associated Drug: Tofogliflozin Csg452
Title: TOFO Insulin Combination Trial
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: TOFOGLIFLOZIN CSG452|DRUG: insulin|DRUG: placebo
Outcome Measures: Primary: Change in HbA1c from baseline, 16 weeks after first intake of investigational product | Secondary: Change of Body Weight (BW) from baseline, 16 weeks after first intake of investigational product|Change of FPG from baseline, 16 weeks after first intake of investigational product|Change of PPG from baseline, 16 weeks after first intake of investigational product|Number of subjects with adverse events, Up to 52 weeks from the first intake of investigational medicinal product
Sponsor/Collaborators: Sponsor: Sanofi | Collaborators: Kowa Company, Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 211
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-06
Completion Date: 2016-10
Results First Posted:
Last Update Posted: 2017-10-11
Locations: Investigational Site Number 392-028, Adachi-ku, Japan|Investigational Site Number 392-007, Atsugi-shi, Japan|Investigational Site Number 392-026, Chuoh-ku, Japan|Investigational Site Number 392-021, Fukuoka-shi, Japan|Investigational Site Number 392-002, Ichihara-shi, Japan|Investigational Site Number 392-012, Iruma-shi, Japan|Investigational Site Number 392-003, Kawaguchi-shi, Japan|Investigational Site Number 392-014, Kitakyusyu-shi, Japan|Investigational Site Number 392-027, Kobe-shi, Japan|Investigational Site Number 392-004, Koga-shi, Japan|Investigational Site Number 392-022, Kunitachi-shi, Japan|Investigational Site Number 392-019, Kurume-shi, Japan|Investigational Site Number 392-001, Kyoto-shi, Japan|Investigational Site Number 392-024, Kyoto-shi, Japan|Investigational Site Number 392-006, Matsudo-shi, Japan|Investigational Site Number 392-008, Mito-shi, Japan|Investigational Site Number 392-030, Musashino-shi, Japan|Investigational Site Number 392-029, Okayama-shi, Japan|Investigational Site Number 392-017, Otsu-shi, Japan|Investigational Site Number 392-011, Sagamihara-shi, Japan|Investigational Site Number 392-020, Sakai-shi, Japan|Investigational Site Number 392-010, Sapporo-shi, Japan|Investigational Site Number 392-016, Sendai-shi, Japan|Investigational Site Number 392-018, Shinjuku-ku, Japan|Investigational Site Number 392-005, Shizuoka-shi, Japan|Investigational Site Number 392-031, Suita-shi, Japan|Investigational Site Number 392-015, Sumida-ku, Japan|Investigational Site Number 392-023, Sunto-gun, Japan|Investigational Site Number 392-013, Tokorozawa-shi, Japan|Investigational Site Number 392-025, Yokohama-shi, Japan
URL: https://clinicaltrials.gov/show/NCT02201004

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress