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Clinical Trial Details

Trial ID: L4173
Source ID: NCT02537834
Associated Drug: Tofogliflozin
Title: Tofogliflozin GLP-1 Analogue Combination Trial
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Tofogliflozin|DRUG: GLP-1 analogue
Outcome Measures: Primary: Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction, baseline and Week 52|Change from Baseline in HbA1c at 52 weeks, Week 52 | Secondary: Change in Fasting plasma glucose, baseline and week 52|Change in Body Weight, baseline and week 52|Change in Blood pressure, baseline and week 52|Change in Uric Acid, baseline and week 52|Change in Total cholesterol, baseline and week 52|Change in HDL-C, baseline and week 52|Change in LDL-C, baseline and week 52|Change in non HDL-C, baseline and week 52|Change in Free Fatty Acid, baseline and week 52
Sponsor/Collaborators: Sponsor: Kowa Company, Ltd. | Collaborators: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 65
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-08
Completion Date: 2017-10
Results First Posted:
Last Update Posted: 2020-11-17
Locations: Atsuta-ku, Aichi, 456-0058, Japan|Minato-ku, Aichi, 455-0018, Japan|Kisarazu, Chiba, 292-0038, Japan|Annaka, Gunma, 379-0116, Japan|Naka, Ibaraki, 311-0113, Japan|Sagamihara, Kanagawa, 252-0302, Japan|Kasaoka, Okayama, 714-0043, Japan|Shimono, Tochigi, 329-0433, Japan|Adachi-ku, Tokyo, 123-0845, Japan|Chuo-ku, Tokyo, 103-0027, Japan|Mitaka, Tokyo, 181-0013, Japan
URL: https://clinicaltrials.gov/show/NCT02537834