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Clinical Trial Details

Trial ID: L1210
Source ID: NCT02015780
Associated Drug: Fasiglifam
Title: Fasiglifam in Type 2 Diabetic Subjects With Chronic Kidney Disease Stage 4 or 5 on Hemodialysis
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Chronic Kidney Disease
Interventions: DRUG: Fasiglifam|DRUG: Placebo|DRUG: Antihyperglycemic therapy
Outcome Measures: Primary: Change from Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16, The change from Baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 16., Baseline and Week 16 | Secondary: Percentage of participants with HbA1c <7.5% at Week 16, Week 16|Change from Baseline in Fasting Plasma Glucose (FPG) at Week 16, Baseline and Week 16|Change from Baseline in Total Daily Dose of Insulin at Week 52, Baseline and Week 52
Sponsor/Collaborators: Sponsor: Takeda
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-12
Completion Date: 2016-01
Results First Posted:
Last Update Posted: 2014-01-27
Locations: Whittier, California, United States|Westminster, Colorado, United States|Tampa, Florida, United States|Rosedale, New York, United States|Cincinnati, Ohio, United States|Charleston, South Carolina, United States|San Antonio, Texas, United States|Pazardzhik, Bulgaria|Sofia, Bulgaria|Varna, Bulgaria|Baja, Hungary|Gyula, Hungary|Kaposvar, Hungary|Szigetvar, Hungary|Zalaegerszeg, Hungary|Zamosc, Poland|Banska Bystrica, Slovakia|Bardejov, Slovakia|Myjava, Slovakia|Puchov, Slovakia|Senica, Slovakia|Svidnik, Slovakia|Trstena, Slovakia|Bloemfontein, Free State, South Africa|Cape Town, Western Cape, South Africa|Worcester, Western Cape, South Africa|Donetsk, Ukraine|Kyiv, Ukraine|Ternopil, Ukraine|Vinnytsia, Ukraine
URL: https://clinicaltrials.gov/show/NCT02015780

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress