Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4560
Source ID: NCT02481141
Associated Drug: 5-Ala-Sfc
Title: Pilot Study to Evaluate the Safety and Efficacy of 5-ALA-SFC in Type II Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02481141/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: 5-ALA-SFC|DRUG: Placebo
Outcome Measures: Primary: Subjects With Adverse Events as a Measure of Safety and Tolerability, The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA - SFC in a population of patients with type 2 diabetes mellitus living in Bahrain., Week 2, Week 4, Week 12|Change From Baseline in Fasting Blood Glucose, The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA - SFC in a population of patients with type 2 diabetes mellitus living in Bahrain., Baseline, Week 2, Week 4, Week 12 | Secondary: Change From Baseline in 2 Hour Post Meal Glucose Level, Change from baseline in blood glucose levels 2 hours after breakfast, Baseline, Week 2, Week 4, Week 12|Change From Baseline in Body Weight, Change from baseline measured at week 6 and week 12 only, Baseline, Week 6, Week 12|Change From Baseline in HbA1c, Change from baseline in HbA1c %, Baseline, Week 2, Week 4, Week 12|Change From Baseline in Total Cholesterol (Component of Lipid Profile), Change from baseline measured at week 6 and week 12 only, Baseline, Week 6, Week 12|Change From Baseline LDL (Component of Lipid Profile), Change from baseline measured at week 6 and week 12 only, Baseline, Week 6, Week 12|Change From Baseline in HDL (Component of Lipid Profile), Change from baseline measured at week 6 and week 12 only, Baseline, Week 6, Week 12|Change From Baseline in Triglycerides (Component of Lipid Profile), Change from baseline measured at week 6 and week 12 only, Baseline, Week 6, Week 12
Sponsor/Collaborators: Sponsor: SBI Pharmaceuticals Co, Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 53
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2014-07
Completion Date: 2015-07
Results First Posted: 2017-12-11
Last Update Posted: 2018-05-22
Locations:
URL: https://clinicaltrials.gov/show/NCT02481141